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:

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.

VP Regulatory & Quality

VP Regulatory & Quality

Job description

Melody Lam