Description: ABOUT US Cerapedics is a global, commercial-stage ortho-biologics company that aspires to transform the standard of care for bone repair, healing bones faster and at higher rates, without compromising safety, so that patients can live their healthiest life. Bone grafts, including Cerapedics' products, are used in over four million annual spine, orthopedics, trauma and interventional procedures world-wide. Cerapedics' product, i-FACTOR, is FDA PMA approved for cervical use in the United States. Cerapedics' next-generation product is currently being evaluated in lumbar interbody fusion through ASPIRE, a pivotal FDA IDE study and has been granted a Breakthrough Device Designation by the FDA. Cerapedics is headquartered in Westminster, CO. OVERVIEW Healing lives through bone repair - this mission is what inspires us every day. If that is inspiring to you as well, consider joining us as an Area Vice President for the Southeast region. The Area Leader is a senior sales leader responsible for executing the commercial strategy within an assigned geographic Area to achieve revenue growth, market expansion, and customer satisfaction goals. This role provides leadership and oversight to all commercial roles within the Area, including Regional Sales Managers, Direct Sales Representatives, and Clinical Sales Representatives, ensuring alignment, accountability, and consistent execution. The Area Leader is accountable for forecasting accuracy, quota attainment, talent development, and aligning the team to national strategic priorities. Specific Functions and Responsibilities: Sales Performance & Forecasting Drive consistent quota attainment across the Area; ensure accurate and timely submission of sales forecasts. Develop Area-level sales plans that align with national objectives and clearly communicate targets and expectations to the field. Monitor performance trends and implement corrective actions proactively. Drive Activities & Resource Utilization Ensure effective use of company resources including MedEd, marketing assets, virtual training, and advance education to drive product awareness and accelerate adoption. Partner closely with Marketing, Medical Education, and Sales Training to optimize execution of FUSE, FOCUSE, PhD programs, and other key initiatives. Reinforce expectations and accountability for activity-based performance. Customer Engagement & Market Development Build and strengthen relationships with key surgeons, hospital stakeholders, sales agents, and distributors. Oversee team engagement strategies, ensuring meaningful participation in surgeon dinners, conferences, and hospital QBRs. Partner with field teams to gather actionable customer insights and competitive intelligence. Performance Management & Talent Development Hold sales team accountable for delivering results that align with company strategy, not exception-based management. Coach, mentor, and develop sales leadership talent; drive succession planning and maintain a strong pipeline of future leaders. Address underperformance directly by implementing performance improvement plans or making necessary personnel decisions. Communicate financial expectations clearly and consistently. Strategic Communication & Storytelling Clearly articulate the Area's commercial strategy, performance drivers, and territory plans to internal and external stakeholders. Ensure consistent utilization of sales tools (e.g. HubSpot) and accurate, timely data entry across the entire team. Support the creation and delivery of plan exercises and quarterly business reviews. Team Leadership & Cross-Functional Collaboration Provide strong leadership that promotes alignment, transparency, accountability, and high performance. Collaborate cross-functionally with Marketing, Operations, Medical Affairs, Sales Operations, and other internal business units to support execution and solve complex problems. Foster a culture of integrity, compliance, and disciplined selling. Recruit and coordinate the training and selling activities of distributors, 1099 Independent sales agents, and direct sales representatives. Manage sales team to meet or exceed area sales objectives. Establish sales objectives by creating a sales plan and quota for area in support of national objectives. Build and maintain relationships with key surgeons and hospital customers. Collect customer and competitor intelligence. Requirements: POSITION REQUIREMENTS: Must be able to effectively communicate (both verbally and in writing) in individual and group situations. Leadership skills include mentoring and team building. Extensive amount of objective and subjective decision-making, and use of judgment in non-routines situations. Extensive amount of planning and prioritizing. Ability to analyze and resolve work problems. Computer literate with knowledge of Microsoft Word, Excel, PowerPoint and Outlook. EDUCATION AND PREFERRED TRAINING REQUIREMENTS: Bachelor's degree (B.S. of B.A.). 10-15+ years of progressive sales leadership experience in the medical device industry, with at least 7 years of experience in spine or spinal biologics and 5 years of experience in core spine. Prior experience leading a region or area with revenue in the range of $15M to $30M Success building, developing, and leading results-focused teams with a strong performance culture - and the ability to be coached through the process. Direct sales leadership of a team greater than 10 people with manager of managers experience. Proven ability to execute a sales cadence (leveraging sales analytics) and then articulate both the plan - and needs - to executive leadership to allow the organization to do all needed to exceed goals. WORK CONDITION/PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodation may be made when requested by the employee to enable individuals with disabilities to perform the essential functions. This position requires the incumbent to regularly utilize written and verbal communication skills, including active listening and speaking clearly and concisely. This position requires the incumbent to experience periods of prolonged sitting and to occasionally stand, walk, carry items, climb, reach, and lift up to 20 lbs. This position requires the incumbent to operate office equipment such as telephones, computers, fax machines, copiers, and to grasp objects utilizing manual dexterity including hand/finger coordination. TRAVEL REQUIREMENTS: 50-70% at times BENEFITS/COMPENSATION (including, but not limited to): Medical and dental insurance, group life insurance , 401k matching, long term disability, potential target bonus, paid time off. SALARY RANGE: $200,000 - $250,000 Target Annual Bonus: + Generous sales bonus target Position will be posted through 03/31/2026 EEO STATEMENT: Cerapedics is an Equal Opportunity Employer. We do not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. Compensation details: 00 Yearly Salary PI75ae6b9e8c5f-3971
04/02/2026
Full time
Description: ABOUT US Cerapedics is a global, commercial-stage ortho-biologics company that aspires to transform the standard of care for bone repair, healing bones faster and at higher rates, without compromising safety, so that patients can live their healthiest life. Bone grafts, including Cerapedics' products, are used in over four million annual spine, orthopedics, trauma and interventional procedures world-wide. Cerapedics' product, i-FACTOR, is FDA PMA approved for cervical use in the United States. Cerapedics' next-generation product is currently being evaluated in lumbar interbody fusion through ASPIRE, a pivotal FDA IDE study and has been granted a Breakthrough Device Designation by the FDA. Cerapedics is headquartered in Westminster, CO. OVERVIEW Healing lives through bone repair - this mission is what inspires us every day. If that is inspiring to you as well, consider joining us as an Area Vice President for the Southeast region. The Area Leader is a senior sales leader responsible for executing the commercial strategy within an assigned geographic Area to achieve revenue growth, market expansion, and customer satisfaction goals. This role provides leadership and oversight to all commercial roles within the Area, including Regional Sales Managers, Direct Sales Representatives, and Clinical Sales Representatives, ensuring alignment, accountability, and consistent execution. The Area Leader is accountable for forecasting accuracy, quota attainment, talent development, and aligning the team to national strategic priorities. Specific Functions and Responsibilities: Sales Performance & Forecasting Drive consistent quota attainment across the Area; ensure accurate and timely submission of sales forecasts. Develop Area-level sales plans that align with national objectives and clearly communicate targets and expectations to the field. Monitor performance trends and implement corrective actions proactively. Drive Activities & Resource Utilization Ensure effective use of company resources including MedEd, marketing assets, virtual training, and advance education to drive product awareness and accelerate adoption. Partner closely with Marketing, Medical Education, and Sales Training to optimize execution of FUSE, FOCUSE, PhD programs, and other key initiatives. Reinforce expectations and accountability for activity-based performance. Customer Engagement & Market Development Build and strengthen relationships with key surgeons, hospital stakeholders, sales agents, and distributors. Oversee team engagement strategies, ensuring meaningful participation in surgeon dinners, conferences, and hospital QBRs. Partner with field teams to gather actionable customer insights and competitive intelligence. Performance Management & Talent Development Hold sales team accountable for delivering results that align with company strategy, not exception-based management. Coach, mentor, and develop sales leadership talent; drive succession planning and maintain a strong pipeline of future leaders. Address underperformance directly by implementing performance improvement plans or making necessary personnel decisions. Communicate financial expectations clearly and consistently. Strategic Communication & Storytelling Clearly articulate the Area's commercial strategy, performance drivers, and territory plans to internal and external stakeholders. Ensure consistent utilization of sales tools (e.g. HubSpot) and accurate, timely data entry across the entire team. Support the creation and delivery of plan exercises and quarterly business reviews. Team Leadership & Cross-Functional Collaboration Provide strong leadership that promotes alignment, transparency, accountability, and high performance. Collaborate cross-functionally with Marketing, Operations, Medical Affairs, Sales Operations, and other internal business units to support execution and solve complex problems. Foster a culture of integrity, compliance, and disciplined selling. Recruit and coordinate the training and selling activities of distributors, 1099 Independent sales agents, and direct sales representatives. Manage sales team to meet or exceed area sales objectives. Establish sales objectives by creating a sales plan and quota for area in support of national objectives. Build and maintain relationships with key surgeons and hospital customers. Collect customer and competitor intelligence. Requirements: POSITION REQUIREMENTS: Must be able to effectively communicate (both verbally and in writing) in individual and group situations. Leadership skills include mentoring and team building. Extensive amount of objective and subjective decision-making, and use of judgment in non-routines situations. Extensive amount of planning and prioritizing. Ability to analyze and resolve work problems. Computer literate with knowledge of Microsoft Word, Excel, PowerPoint and Outlook. EDUCATION AND PREFERRED TRAINING REQUIREMENTS: Bachelor's degree (B.S. of B.A.). 10-15+ years of progressive sales leadership experience in the medical device industry, with at least 7 years of experience in spine or spinal biologics and 5 years of experience in core spine. Prior experience leading a region or area with revenue in the range of $15M to $30M Success building, developing, and leading results-focused teams with a strong performance culture - and the ability to be coached through the process. Direct sales leadership of a team greater than 10 people with manager of managers experience. Proven ability to execute a sales cadence (leveraging sales analytics) and then articulate both the plan - and needs - to executive leadership to allow the organization to do all needed to exceed goals. WORK CONDITION/PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodation may be made when requested by the employee to enable individuals with disabilities to perform the essential functions. This position requires the incumbent to regularly utilize written and verbal communication skills, including active listening and speaking clearly and concisely. This position requires the incumbent to experience periods of prolonged sitting and to occasionally stand, walk, carry items, climb, reach, and lift up to 20 lbs. This position requires the incumbent to operate office equipment such as telephones, computers, fax machines, copiers, and to grasp objects utilizing manual dexterity including hand/finger coordination. TRAVEL REQUIREMENTS: 50-70% at times BENEFITS/COMPENSATION (including, but not limited to): Medical and dental insurance, group life insurance , 401k matching, long term disability, potential target bonus, paid time off. SALARY RANGE: $200,000 - $250,000 Target Annual Bonus: + Generous sales bonus target Position will be posted through 03/31/2026 EEO STATEMENT: Cerapedics is an Equal Opportunity Employer. We do not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. Compensation details: 00 Yearly Salary PI75ae6b9e8c5f-3971
Description: ABOUT US Cerapedics is a global, commercial-stage ortho-biologics company that aspires to transform the standard of care for bone repair, healing bones faster and at higher rates, without compromising safety, so that patients can live their healthiest life. Bone grafts, including Cerapedics' products, are used in over four million annual spine, orthopedics, trauma and interventional procedures world-wide. Cerapedics' product, i-FACTOR, is FDA PMA approved for cervical use in the United States. Cerapedics' next-generation product is currently being evaluated in lumbar interbody fusion through ASPIRE, a pivotal FDA IDE study and has been granted a Breakthrough Device Designation by the FDA. Cerapedics is headquartered in Westminster, CO. OVERVIEW Healing lives through bone repair - this mission is what inspires us every day. If that is inspiring to you as well, consider joining us as a Medical Education Program Mangager in our Westminster office. In this role, you will contribute to our mission through leading the strategic planning, execution, and continuous improvement of Cerapedics' regional medical education programs. As a Medical Education Program Manager working on the Medical Education team, you will be empowered through meaningful work and career development to independently manage complex surgeon-focused programs, drive operational excellence, and strengthen engagement with HCP faculty, regional PhD Manager, and Area Leaders, and a typical day will include- ensuring educational activities are compliant, scalable, and aligned with commercial and scientific objectives. POSITION OBJECTIVES: Program Strategy, Planning & Execution Lead the end-to-end development, implementation, and execution of regional medical education programs, including podium events, workshops, peer-to-peer education, and speaker activities. Translate educational and commercial priorities into structured program plans, timelines, and deliverables. Ensure speaker training, faculty onboarding, content preparation, and compliance submissions are completed accurately and on time. Program Development & Faculty Engagement Build and strengthen relationships with HCP faculty, KOLs, and emerging surgeon educators to support program growth and excellence. Support collaboration with Med Ed Ph D team and area leaders to identify educational needs and develop relevant programming. Oversee development of program communications and promotional materials (emails, landing pages, program summaries). Program Analysis, Reporting & Optimization Evaluate program effectiveness using quantitative and qualitative data; provide insights and recommendations for continuous improvement. Track key performance indicators and prepare recurring dashboards and leadership updates. Apply data-driven insights to refine program structure, content, and faculty usage. Cross-Functional Collaboration & Communication Serve as the primary program lead across Medical Education, Marketing and Commercial Teams Partner closely with field teams to ensure alignment on program objectives, faculty needs, attendee engagement, and logistics. Communicate program strategy, execution status, risks, and post-program outcomes to stakeholders. Budget & Vendor Management Own the budget for assigned programs, ensuring accurate forecasting, cost management, and reconciliation. Manage external vendors, event logistics partners, and internal resources to ensure high-quality program delivery. Requirements: POSITION REQUIREMENTS: Demonstrated success leading complex educational programs with HCP audiences. Strong cross-functional communication skills and proven ability to engage with surgeons, KOLs, and senior internal stakeholders. Expertise in planning and executing national/regional medical education events. Experience with HCP contracting, SOW management, Sunshine Act requirements, and compliance reporting. Proven ability to analyze program data and generate meaningful insights to drive decision-making. Highly organized, proactive, and able to manage multiple concurrent priorities in a fast-paced environment. EDUCATION AND PREFERRED TRAINING REQUIREMENTS: Bachelor's degree required; advanced degree preferred. 7+ years of experience in medical education, HCP engagement, program management, or related healthcare roles. WORK CONDITION/PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodation may be made when requested by the employee to enable individuals with disabilities to perform the essential functions. This position requires the incumbent to regularly utilize written and verbal communication skills, including active listening and speaking clearly and concisely. This position requires the incumbent to experience periods of prolonged sitting and to occasionally stand, walk, carry items, climb, reach, and lift up to 20 lbs. This position requires the incumbent to operate office equipment such as telephones, computers, fax machines, copiers, and to grasp objects utilizing manual dexterity including hand/finger coordination. BENEFITS/COMPENSATION (including, but not limited to): Medical and dental insurance, group life insurance , 401k matching, long term disability, potential target bonus, paid time off. SALARY RANGE: $120,000 - $150,000 Base Salary: Annually Target Annual Bonus: Up to 15% This position will be posted through 04/26/2026 EEO STATEMENT: Cerapedics is an Equal Opportunity Employer. We do not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. Compensation details: 00 Yearly Salary PI785bda5942d1-0667
04/02/2026
Full time
Description: ABOUT US Cerapedics is a global, commercial-stage ortho-biologics company that aspires to transform the standard of care for bone repair, healing bones faster and at higher rates, without compromising safety, so that patients can live their healthiest life. Bone grafts, including Cerapedics' products, are used in over four million annual spine, orthopedics, trauma and interventional procedures world-wide. Cerapedics' product, i-FACTOR, is FDA PMA approved for cervical use in the United States. Cerapedics' next-generation product is currently being evaluated in lumbar interbody fusion through ASPIRE, a pivotal FDA IDE study and has been granted a Breakthrough Device Designation by the FDA. Cerapedics is headquartered in Westminster, CO. OVERVIEW Healing lives through bone repair - this mission is what inspires us every day. If that is inspiring to you as well, consider joining us as a Medical Education Program Mangager in our Westminster office. In this role, you will contribute to our mission through leading the strategic planning, execution, and continuous improvement of Cerapedics' regional medical education programs. As a Medical Education Program Manager working on the Medical Education team, you will be empowered through meaningful work and career development to independently manage complex surgeon-focused programs, drive operational excellence, and strengthen engagement with HCP faculty, regional PhD Manager, and Area Leaders, and a typical day will include- ensuring educational activities are compliant, scalable, and aligned with commercial and scientific objectives. POSITION OBJECTIVES: Program Strategy, Planning & Execution Lead the end-to-end development, implementation, and execution of regional medical education programs, including podium events, workshops, peer-to-peer education, and speaker activities. Translate educational and commercial priorities into structured program plans, timelines, and deliverables. Ensure speaker training, faculty onboarding, content preparation, and compliance submissions are completed accurately and on time. Program Development & Faculty Engagement Build and strengthen relationships with HCP faculty, KOLs, and emerging surgeon educators to support program growth and excellence. Support collaboration with Med Ed Ph D team and area leaders to identify educational needs and develop relevant programming. Oversee development of program communications and promotional materials (emails, landing pages, program summaries). Program Analysis, Reporting & Optimization Evaluate program effectiveness using quantitative and qualitative data; provide insights and recommendations for continuous improvement. Track key performance indicators and prepare recurring dashboards and leadership updates. Apply data-driven insights to refine program structure, content, and faculty usage. Cross-Functional Collaboration & Communication Serve as the primary program lead across Medical Education, Marketing and Commercial Teams Partner closely with field teams to ensure alignment on program objectives, faculty needs, attendee engagement, and logistics. Communicate program strategy, execution status, risks, and post-program outcomes to stakeholders. Budget & Vendor Management Own the budget for assigned programs, ensuring accurate forecasting, cost management, and reconciliation. Manage external vendors, event logistics partners, and internal resources to ensure high-quality program delivery. Requirements: POSITION REQUIREMENTS: Demonstrated success leading complex educational programs with HCP audiences. Strong cross-functional communication skills and proven ability to engage with surgeons, KOLs, and senior internal stakeholders. Expertise in planning and executing national/regional medical education events. Experience with HCP contracting, SOW management, Sunshine Act requirements, and compliance reporting. Proven ability to analyze program data and generate meaningful insights to drive decision-making. Highly organized, proactive, and able to manage multiple concurrent priorities in a fast-paced environment. EDUCATION AND PREFERRED TRAINING REQUIREMENTS: Bachelor's degree required; advanced degree preferred. 7+ years of experience in medical education, HCP engagement, program management, or related healthcare roles. WORK CONDITION/PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodation may be made when requested by the employee to enable individuals with disabilities to perform the essential functions. This position requires the incumbent to regularly utilize written and verbal communication skills, including active listening and speaking clearly and concisely. This position requires the incumbent to experience periods of prolonged sitting and to occasionally stand, walk, carry items, climb, reach, and lift up to 20 lbs. This position requires the incumbent to operate office equipment such as telephones, computers, fax machines, copiers, and to grasp objects utilizing manual dexterity including hand/finger coordination. BENEFITS/COMPENSATION (including, but not limited to): Medical and dental insurance, group life insurance , 401k matching, long term disability, potential target bonus, paid time off. SALARY RANGE: $120,000 - $150,000 Base Salary: Annually Target Annual Bonus: Up to 15% This position will be posted through 04/26/2026 EEO STATEMENT: Cerapedics is an Equal Opportunity Employer. We do not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. Compensation details: 00 Yearly Salary PI785bda5942d1-0667
Description: ABOUT US Cerapedics is a global, commercial-stage ortho-biologics company that aspires to transform the standard of care for bone repair, healing bones faster and at higher rates, without compromising safety, so that patients can live their healthiest life. Bone grafts, including Cerapedics' products, are used in over four million annual spine, orthopedics, trauma and interventional procedures world-wide. Cerapedics' product, i-FACTOR, is FDA PMA approved for cervical use in the United States. Cerapedics' next-generation product is currently being evaluated in lumbar interbody fusion through ASPIRE, a pivotal FDA IDE study and has been granted a Breakthrough Device Designation by the FDA. Cerapedics is headquartered in Westminster, CO. OVERVIEW Healing lives through bone repair - this mission is what inspires us every day. If that is inspiring to you as well, consider joining us as a Regulatory Affairs Manager. In this role, you will contribute to our mission through assisting with managing and executing the activities of Regulatory Affairs. As a Regulatory Affairs Manager working on the Regulatory Affairs team, you will be empowered through meaningful work and career development to coordinate closely with cross-functional partners and others on the development, submission, and prosecution of Regulatory filings. POSITION OBJECTIVES: Develop, author, assemble, publish and submit IDE Annual Reports, Post-Approval Study Annual Reports, and PMA Annual Reports, ensuring timely submission in accordance with FDA Approvals. Work collaboratively with subject matter experts and business partners to identify and gather data required for submission, including data from clinical, non-clinical, and manufacturing. Monitor regulatory changes and assess their impact on organizational processes and products. Review and approve technical documentation (e.g. protocols, reports, procedures) to ensure alignment with the PMAs. Evaluate changes for incorporation into an Annual Report or other post-market submission. Maintain FDA device listing and site registration. Collaborate with stakeholders such as R&D, Engineering, Quality, Clinical and Operations teams to ensure regulatory alignment. Requirements: POSITION REQUIREMENTS: Good planning and prioritization skills. Strong interpersonal and team skills. Strong decision-making skills. Good writing skills. Good computer and word processing skills. Adaptable to various job duties as necessary. EDUCATION AND PREFERRED TRAINING REQUIREMENTS: Minimum of a technical college degree in scientific discipline, in combination with applicable training. Minimum of 4 years of experience in US Class III medical device regulatory affairs. Experience in drug/device combination product regulatory affairs preferred. Experience with global regulatory affairs preferred. WORK CONDITION/PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodation may be made when requested by the employee to enable individuals with disabilities to perform the essential functions. This position requires the incumbent to regularly utilize written and verbal communication skills, including active listening and speaking clearly and concisely. This position requires the incumbent to experience periods of prolonged sitting and to occasionally stand, walk, carry items, climb, reach, and lift up to 20 lbs. This position requires the incumbent to operate office equipment such as telephones, computers, fax machines, copiers, and to grasp objects utilizing manual dexterity including hand/finger coordination. Moderate to minimal supervision. A wide degree of latitude is expected. Relies on experience and judgment to plan. TRAVEL REQUIREMENTS: N/A BENEFITS/COMPENSATION (including, but not limited to): Medical, vision, and dental insurance, group life insurance, 401k matching, short- & long-term disability, potential target bonus, paid time off, 11 paid holidays. SALARY RANGE: $130,000 - $140,000 Base Salary: Annually Target Annual Bonus: 15% Position will be posted through: March 31, 2026 EEO STATEMENT: Cerapedics is an Equal Opportunity Employer. We do not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. Compensation details: 00 Yearly Salary PIeafd-9283
04/01/2026
Full time
Description: ABOUT US Cerapedics is a global, commercial-stage ortho-biologics company that aspires to transform the standard of care for bone repair, healing bones faster and at higher rates, without compromising safety, so that patients can live their healthiest life. Bone grafts, including Cerapedics' products, are used in over four million annual spine, orthopedics, trauma and interventional procedures world-wide. Cerapedics' product, i-FACTOR, is FDA PMA approved for cervical use in the United States. Cerapedics' next-generation product is currently being evaluated in lumbar interbody fusion through ASPIRE, a pivotal FDA IDE study and has been granted a Breakthrough Device Designation by the FDA. Cerapedics is headquartered in Westminster, CO. OVERVIEW Healing lives through bone repair - this mission is what inspires us every day. If that is inspiring to you as well, consider joining us as a Regulatory Affairs Manager. In this role, you will contribute to our mission through assisting with managing and executing the activities of Regulatory Affairs. As a Regulatory Affairs Manager working on the Regulatory Affairs team, you will be empowered through meaningful work and career development to coordinate closely with cross-functional partners and others on the development, submission, and prosecution of Regulatory filings. POSITION OBJECTIVES: Develop, author, assemble, publish and submit IDE Annual Reports, Post-Approval Study Annual Reports, and PMA Annual Reports, ensuring timely submission in accordance with FDA Approvals. Work collaboratively with subject matter experts and business partners to identify and gather data required for submission, including data from clinical, non-clinical, and manufacturing. Monitor regulatory changes and assess their impact on organizational processes and products. Review and approve technical documentation (e.g. protocols, reports, procedures) to ensure alignment with the PMAs. Evaluate changes for incorporation into an Annual Report or other post-market submission. Maintain FDA device listing and site registration. Collaborate with stakeholders such as R&D, Engineering, Quality, Clinical and Operations teams to ensure regulatory alignment. Requirements: POSITION REQUIREMENTS: Good planning and prioritization skills. Strong interpersonal and team skills. Strong decision-making skills. Good writing skills. Good computer and word processing skills. Adaptable to various job duties as necessary. EDUCATION AND PREFERRED TRAINING REQUIREMENTS: Minimum of a technical college degree in scientific discipline, in combination with applicable training. Minimum of 4 years of experience in US Class III medical device regulatory affairs. Experience in drug/device combination product regulatory affairs preferred. Experience with global regulatory affairs preferred. WORK CONDITION/PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodation may be made when requested by the employee to enable individuals with disabilities to perform the essential functions. This position requires the incumbent to regularly utilize written and verbal communication skills, including active listening and speaking clearly and concisely. This position requires the incumbent to experience periods of prolonged sitting and to occasionally stand, walk, carry items, climb, reach, and lift up to 20 lbs. This position requires the incumbent to operate office equipment such as telephones, computers, fax machines, copiers, and to grasp objects utilizing manual dexterity including hand/finger coordination. Moderate to minimal supervision. A wide degree of latitude is expected. Relies on experience and judgment to plan. TRAVEL REQUIREMENTS: N/A BENEFITS/COMPENSATION (including, but not limited to): Medical, vision, and dental insurance, group life insurance, 401k matching, short- & long-term disability, potential target bonus, paid time off, 11 paid holidays. SALARY RANGE: $130,000 - $140,000 Base Salary: Annually Target Annual Bonus: 15% Position will be posted through: March 31, 2026 EEO STATEMENT: Cerapedics is an Equal Opportunity Employer. We do not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. Compensation details: 00 Yearly Salary PIeafd-9283