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VP Regulatory & Quality
- Posted 09 September 2024
- LocationUnited States of America
- Job type Permanent
- Reference203312
- Contact NameMelody Lam
Job description
We are a California-based medical device company focused on the design, development, and commercialization of a comprehensive portfolio of systems, products, and technologies for spine surgery procedures.
Position Responsibilities:
Experience and Education
Position Responsibilities:
- Mentoring and developing team members to reach their full potential
- Conducting training needs assessments to identify opportunities for service delivery improvement and value add to the company.
- Interpreting regulatory rules or rule changes and ensuring that they are communicated through corporate policies and procedures.
- Anticipating potential regulatory issues or risks and proactively offering solutions and strategies.
- Updating internal procedures to ensure compliance with all national and international regulations.
- Work directly with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
- Host FDA inspectors and provide responses for any follow up actions required.
- Coordinating, preparing, or reviewing regulatory submissions for domestic and international projects.
Experience and Education
- Bachelor’s degree with a minimum of 15+ years of experience in quality assurance and regulatory affairs within a regulated environment
- Minimum of 8-10+ years of management experience required.
- A successful track record in preparing multiple regulatory submissions for medical devices (PMA, 510(k)).
- Experience with international submissions and regulations.
- Experienced in Quality System compliance and strategy.
- Strong understanding of ISO 13485, 21 CFR 820, MDSAP, and EU MDR regulations.
