VP Quality and Regulatory Affairs

VP Quality and Regulatory Affairs (Medical Device), San Diego, CA

Rapidly growing medical device company is looking for an expert with a go-getter attitude who can bring strong Regulatory submissions and Quality compliance knowledge experience to the table, and in return they’re offering opportunities to grow and lead in an exciting, fast-paced environment. 
 

What You'll Do:
 

• 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.
• Manage the preparation and development of regulatory submission packages.
• Oversee all areas of quality assurance systems.
• Management review of quality and regulatory team.
• Oversee document control, internal and external audits, complaint system, CAPA, NCMRs, and key supplier qualifications.
• ISO 13485 regulated

Who you are:

• 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.

What does this position pay? 

Compensation is determined by several factors which may include skillset, experience level, and geographic location. 

The expected range for this role is $175K-225K

Please note this range is an estimate and actual pay may vary based on qualifications and experience.

Please email your resume to sboddy@provenrecruiting.com if you’d like to work alongside some of the finest scientists in the pharmaceutical industry!

Note: We actively support and promote people of various backgrounds, from race, religion, gender to geographical area, university, lifestyle, and personality type. Proven Recruiting is minority-owned, majority women, and is a strong advocate for diversity and inclusion in the broader community. Apply today!

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