Director of Regulatory Affairs – FILLED
The Wellington Group is seeking an experienced Director of Regulatory Affairs for an exciting new medical device / combination therapy position. Excellent opportunity to help bring new medical devices to the global market!
The Director of Regulatory Affairs is a key role in the development, research and commercialization of new products and the management of regulatory and quality disciplines for the organization. Â The Director will ensure that the company complies with applicable global regulatory requirements and standards for the development, pre-clinical and clinical evaluation, manufacturing, and marketing of its products. Â
Responsibilities include:
- Lead a team of regulatory professionals to define and implement the regulatory strategy
- Lead the preparation, submission, and timely approval of regulatory applications
- Lead the interaction and negotiations with regulatory agencies
- Maintain regulatory procedures and documents to maintain approvals and certification for development, manufacturing, and marketing of products
- Inform senior management of regulatory requirements and status of products and significant regulatory issues/trends
The qualified candidate will have:
- 10+ years of Regulatory Affairs experience with at least 4 years of medical devices and 4 years in senior manager
- 4-year degree required, graduated degree preferred
- Experience in providing regulatory direction to development, pre-clinical and clinical evaluation, manufacturing, and marketing of combination products
- Experience in preparing and obtaining approval of device/drug combination products
- FDA/ISO/CE submissions and follow-up maintenance activities for approvals and certifications
- Significant experience planning for and management of regulatory compliance audits
Industry: Medical Devices, Biologics, Pharmaceutical
Location: Either RTP, NC or Cambridge, MA
Permanent position with an employee centered company offering great benefits, salary, bonus and relocation assistance.
Don’t wait, apply with The Wellington Group today!
(all information will be held in the strictest of confidence)