Connecting linkedin

W1siziisimnvbxbpbgvkx3rozw1lx2fzc2v0cy9oyw1sew4td2lsbglhbxmvanbnl2jhbm5lci1kzwzhdwx0lwpvyi5qcgcixv0

Job

VP of Regulatory Affairs

  • Location

    Illinois

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    Competitive

  • Contact:

    Cortland Hotz

  • Contact email:

    c.hotz@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    9 months ago

  • Expiry date:

    2020-04-01

  • Startdate:

    ASAP

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