Regulatory Affairs Specialist, Medical Device

This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly. This role is full-time and you may be eligible for healthcare and retirement benefits and paid time off.

OVERALL RESPONSIBILITIES:
The Regulatory Affairs Specialist II is responsible for regulatory activities to support new, modified and currently marketed medical devices in the DePuy line of products. This includes the preparation of regulatory documentation for submission to regulatory authorities (e.g., IDE, 510(k), PMA, Technical File, Design Dossiers, and Technical Documentation) or internal regulatory assessment documentation. The regulatory specialist is also responsible for the review and approval of all device labeling and product support information used in the promotion and educational activities of DePuy Synthes products for compliance to global regulations and company policies and procedures.

DUTIES:
• Prepare and/or assist in preparation of regulatory documentation for DePuy devices, including IDE, 510(k), PMA, Technical File, Design Dossier, and Technical Documentation for submission to regional Health authorities. This includes the resolution of regulatory issues and questions from regulatory agencies during the pre-market product development phase.
• Assist in the preparation of approval documents to support rest of world registrations, such as EU CE marking activities, as required.
• Review engineering changes to currently marketed products and prepare internal regulatory assessments for documenting decisions to submit or not to submit in accordance with relevant regulations and guidance.
• Review product labeling and product support information for currently marketed products to ensure that product information and claims are consistent with premarket clearances and approvals and in compliance with relevant regulations and guidance.
• Maintain current knowledge to ensure compliance to the applicable regulatory and corporate standards/requirements (FDA Quality System Regulations, European Quality Standards and presiding Medical Device Regulation, ISO 13485, previous MDD, MDR, etc.).
• Perform other duties as assigned.

PROFESSIONAL EXPERIENCE REQUIREMENTS:
• Minimum 2 years of prior regulatory experience in medical devices, 5 years of experience preferred
• Knowledge and/or Familiarity of U.S. FDA and EU Medical Device Regulations MDR (and previous MDD) and presiding guidances and standards
• Knowledge of orthopedic implants a plus
• Familiarity with G10 regulations and guidance a plus
• Familiarity with electronic submission preparation a plus
• Excellent written and oral communication skills
• Ability to handle multiple tasks and be detail oriented

EDUCATIONAL REQUIREMENTS:
• BA/BS Degree required; advanced degree or equivalent work experience preferred

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