Senior Principal Regulatory Affair Specialist
$157,600–$236,400 year
RemoteUnited States
Job Summary
Lead global regulatory strategies for Class I, II, and III therapy and diagnostic devices, including developing submission deliverables, timelines, and strategic direction. Review and approve technical documentation, preparing FDA, IDE, PMA, and 510(k) submissions for new products and changes to ensure timely approvals. Collaborate with Marketing, Legal, Clinical, and Quality stakeholders to coordinate review cycles, resolve regulatory agency questions, and negotiate with authorities for product registration and commercialization. Provide ongoing support to product development teams and manage product change assessments for global markets. Maintain proficiency in global regulatory requirements, quality policies, and ISO standards while advising senior management on regulatory status and significant issues.
Required Qualifications
- Bachelor's degree
- Minimum of 10 years of medical device regulatory affairs experience
- Advanced degree with a minimum of 8 years of medical device regulatory affairs experience
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A)
- U.S. work authorization at the time of hire and for the duration of employment
Desired Qualifications
- Proven expertise in all aspects of Regulatory Affairs
- Strategy Planning
- US and major market regulatory requirements
- project management
- negotiations
- Solid understanding of manufacturing and change control
- an awareness of regulatory trends
- Advanced degree in a scientific discipline (engineering, physical/biological or health sciences)
- Ability to comprehend principles of engineering, physiology and medical device use
- Good analytical and critical thinking skills
- International regulatory agency requirements
- ISO I GHTF standards
- Experience performing advertising and promotion reviews for medical devices
- Product development experience
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