Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries
At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. Thatu2019s why weu2019re focused on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions. Weu2019re revolutionizing the way people monitor their glucose levels with our new sensing technology.
Our location in Alameda, CA currently has an opportunity for a Senior Regulatory Affairs Specialist.u00A0
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This new Senior Regulatory Affairs Specialist position at ADC will focus on US regulatory submissions and change management for our next generation sensing products. Prior FDA submission experience or a background in software products is preferred, as well as project management experience. This is an exciting opportunity to lead submissions for new products in evolving regulatory areas such as the digital space.
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As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment.u00A0 The individual may execute tasks and play a consultative role by partnering across business functions, contract manufacturers, and suppliers.u00A0 The individual may assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for FDA submission.u00A0 The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation. This is a broad scoped position with strong opportunity for growth and career development.
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WHAT YOUu2019LL DO
Assist in SOP development and review
Provide regulatory input to product lifecycle planning
Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions
Assist in the development of regional regulatory strategy
Understand, investigate and evaluate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval
Determine trade issues to anticipate regulatory obstacle
Determine and communicate submission and approval requirements
Participate in risk benefit analysis for regulatory compliance
Assess the acceptability of quality, preclinical and clinical documentation for submission filing
Compile, prepare, review and submit regulatory submission to authorities
Monitor impact of changing regulations on submission strategies
Monitor applications under regulatory review
Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies
Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval
Assist compliance with product post marketing approval requirements
Review regulatory aspects of contracts
Assist with label development and review for compliance before release
Submit and review change controls to determine the level of change and consequent submission requirements
Provide regulatory input for product recalls and recall communications.
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EDUCATION AND EXPERIENCE YOUu2019LL BRING
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At least three (3) years of regulatory affairs experience within medical devices (preferred) or pharma, ideally with class III PMA products. FDA/EU or international regulatory experience is required. Bachelors degree (or equivalent); Bachelors degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.u00A0 Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
Learn more about our benefits that add real value to your life to help you live fully:u00A0
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Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.
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