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VP of Regulatory Affairs

  • Location


  • Sector:

    Life Sciences

  • Job type:


  • Salary:


  • Contact:

    Cortland Hotz

  • Contact email:

  • Salary high:


  • Salary low:


  • Published:

    about 1 year ago

  • Expiry date:


  • Startdate:


Position Summary: VP of RA is responsible for developing and implementing (RSTP) for market products or products in development. This candidate must be able to utilize knowledge of scientific, regulatory & business issues to enable development and commercialization of products to meet relevant regulatory requirements.


Key Responsibilities include:

  • Serve as the primary corporate liaison / contact with domestic and/or international regulatory agencies (e.g., FDA Investigators, Notified Body Auditors) regarding the quality management system)
  • ISO Management Representative
  • Host FDA, Canada Health, European Union, ISO audits
  • Medical Device Reports as appropriate to the FDA, Health Canada and the European Union
  • Post market surveillance monitoring, reports including product complaints and MDRs
  • Prepare and present to management tracking metrics for RA area activities, customer complaints/ MDRs
  • Manages interface with Health Authority (FDA) for key projects/issues, including direct collaboration with review division personnel
  • Demonstrates excellent negotiation skills, problem solving skills and builds consensus
  • Able to deliver challenging messages effectively without compromising important business relationships

Minimum Qualifications

  • Bachelor’s Degree in life sciences, relevant advanced degree and certification is preferred
  • 15-20 years Regulatory, R&D or Industry-related experience
  • 8-10 years in injectable pharmaceutical RA
  • Proven skill at implementing successful US and Canada regulatory strategies; global regulatory experience is a plus