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