Behind DEKA’s brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. New ideas are always welcome and explored to make the Manchester Millyard a place to create some of the most innovative and life-changing products of our time. Our employees enjoy the benefits of living and working an hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research and Development, where we are taking same innovation and cutting-edge technology into the modern age.
DEKA develops its talented employees through hands on learning and encourages future engineers through FIRST Robotics. We are proud of this aspect of our culture and are always looking to grow our family at DEKA.
DEKA Research & Development has an immediate opening for a Senior Regulatory Affairs Project Manager to contribute to a dynamic medical device research and development environment. The individual in this high visibility role will have a significant and direct impact on the success of the innovative life science devices that DEKA develops. He or she will formulate and execute regulatory strategies to deliver FDA approval or clearance as well as obtain the CE Mark and other international approvals.
How you will make an impact:
- Work in close association with customers and development teams to establish regulatory requirements and approval strategies
- Define and execute regulatory approval programs, with focus on the preparation and submission of 510(k)s, PMAs, IDEs, Technical Files, etc.
- Lead FDA interactions including in-person meetings, teleconferences, and other Agency communications as needed
- Participate in the design and conduct of clinical trials, including leading efforts to obtain and maintain the appropriate regulatory approvals from the FDA, IRBs and/or Ethics Boards
- Continually improve internal regulatory processes and procedures to increase efficiency and reduce time to market while maintaining the highest levels of compliance
- Insure the organization stays up to date on changes to requirements through regulatory intelligence monitoring
- Coach and mentor internal and external partners on effective regulatory strategies and tactics
- Interface with our customers on regulatory issues
To be successful in this role, you will need the following skills and experience:
- BS in a technically related field
- Minimum of 7-10+ years direct work experience in a medical device regulatory role with demonstrated success in obtaining product approvals/clearances
- Experience in direct FDA interactions including premarket notifications, IDE’s, Q-submissions and in-person meetings
- Experience in medical device regulations including U.S. FDA Quality Systems Regulations (QSRs), ISO 13485, EU MDR, product registrations, UDI, product labeling, and CE Marking requirements
- RAC certification a plus
- Experience in drug, biologic and combination products a plus
- Experience in product development of medical devices a plus