VP of Regulatory Affairs
-
Location
Illinois
-
Sector:
-
Job type:
-
Salary:
Competitive
-
Contact:
Cortland Hotz
-
Contact email:
c.hotz@hamlynwilliams.com
-
Salary high:
0
-
Salary low:
0
-
Published:
11 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