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- Scientific And Regulatory Affairs
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Vp Quality And Regulatory Affairs
Company | Proven Recruiting |
Address | San Diego, CA, United States |
Employment type | FULL_TIME |
Salary | |
Category | Staffing and Recruiting |
Expires | 2023-09-24 |
Posted at | 8 months ago |
VP Quality and Regulatory Affairs (Medical Device), San Diego, CA
- ISO 13485 regulated
- Management review of quality and regulatory team.
- Oversee document control, internal and external audits, complaint system, CAPA, NCMRs, and key supplier qualifications.
- Manage the preparation and development of regulatory submission packages.
- Oversee all areas of quality assurance systems.
- Responsible for regulatory submission strategies to support product development and approval of various medical device products.
- Interface with regulatory authorities and internal technical teams on regulatory submissions.
- Bachelor’s degree in the sciences with minimum of 10 years in GMP/GLP environment with three years’ experience in a Class III medical device regulatory environment.
- Prior experience authoring and filing of regulatory documents.
- Proficency with CE Mark applications and US Pre-Market Approval Applications (PMAs) for product approvals.
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