Principal Regulatory Affairs Specialist

Principal Regulatory Affairs Specialist

The Principal Regulatory Affairs Specialist will lead strategic regulatory initiatives and projects as subject matter expert which support both domestic and international market authorization and compliance including working with Marketing, New Product Development, Manufacturing and Engineering.

Responsibilities :

• Lead strategic regulatory initiatives and projects to ensure regulatory approval and compliance of medical devices in both domestic and international markets. Provide regulatory affairs expertise for aspects of product development, product manufacturing, and / or clinical studies including pre-market, post-market and physician initiated studies. Provide Regulatory support to on-going compliance and corporate initiatives.
• Compile and submit documentation as required in support of marketing initiatives.
• Represent Regulatory Affairs on strategy and compliance project teams in areas of expertise.
• Lead or support the expert review of pre-market filings as appropriate (Q-Sub, 510(k), IDE, PMA, PMA updates, CE Marking, Canadian Registrations, EU Registrations, and ROW registrations).
• Lead in planning, creating, organizing and interpreting regulatory documents for strategic regulatory initiatives.
• Review and approve project documentation such as specifications, procedures, schedules, test protocols and reports, validations, etc, as required depending on project.
• Performs other duties as required.

Education and Experience :

Preferred Skills and Competencies :