San Francisco, CA
8 months ago
Director of Regulatory Affairs
Location: San Carlos, CA
Type: Full Time Permanent
Salary: Excellent salary, bonus and accompanying benefits package
Amazing opportunity with a Biotech company focused in women's health and oncology. In this leadership position, you will direct multiple projects of their functional teams with limited oversight, provides instruction, guidance, and regulatory interpretations to functional staff. An ideal candidate has experience with worldwide clearance/approval/registration of products as well as a background in Oncology, Cord Blood, Biologics or Pharmacology.
- Assesses regulatory pathways for new product platforms and product modifications
- Represents Regulatory Affairs function in interactions/negotiations with U.S. regulatory agencies.
- Represents Regulatory Affairs function in external activities benefiting business interests
- Responsible for oversight of current and new regulatory requirements for the U.S., EU
- Manages a staff of regulatory professionals
- Manages the preparation and filing of premarket submissions and Technical Files.
- Manages the regulatory review of labels, labeling, and promotional materials.
- Develops direct reports with regard to required competencies
- Designs and implements training on regulatory issues
- Provides recommendations for Regulatory Affairs functional budget.
- Complete necessary training requirements
- Must maintain a current status on training requirements.
- Pass post offer criminal background check.
- Bachelor’s degree in a technical discipline
- Minimum 8 years of regulatory experience in the medical device and/or IVD
- PMA experience is preferred
- Minimum of 4/5 years managerial experience.
- Must be able to interpret regulatory requirements.
My team and I manage a slew of other full-time and contract positions for large, mid-size, and start up companies across the US (Pharma, Biotech, and Medical Device). If the above role isn’t for you but you’d nevertheless like to discuss your options in the market, I’d welcome a confidential discussion by phone or email. Please feel to reach out directly: (619) 350 - 6195 and/or firstname.lastname@example.org