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
- 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.
Donâ€™t wait, apply with The Wellington Group today!
(all information will be held in the strictest of confidence)