Manager, Regulatory Affairs
The Manager of Regulatory Affairs reports to the Chief Quality and Regulatory Affairs Officer and is an independent contributor. Responsibilities include managing and supporting a variety of regulatory projects, including:
- Preparing and submitting worldwide product registrations in Nova’s marketplace which includes Asia/Pacific, the EC,Canada and the US.
- Developing and communicating regulatory strategies for worldwide markets.
- Coordinating recalls, field actions and product holds, as well as, participating in internal and external audits of quality systems
- Submitting facility registrations and product listings, ISO and EC certificate maintenance, as well as, maintaining foreign registrations.
- Interfacing and negotiating with regulatory agencies for new products and compliance-related issues.
- Identifying areas within the Company requiring regulatory affairs compliance improvement.
This position requires a BA/BS in business, engineering, or within a medical or a science discipline. A minimum of 10 years of regulatory affairs experience within the medical device industry. In Vitro Diagnostic (IVD) product experience a plus. Extensive experience and understanding of ISO/FDA, QSR, IVDD, ISO 13485, ISO 15197 and ISO 14971 requirements. The role requires strong technical writing, analytical and statistical skills. RAPS certification.