Regulatory Affairs Project Manager

• Represent Regulatory Affairs on R&D product development project teams to ensure all regulatory requirements are met throughout the development process
• Define and execute regulatory approval programs, with focus on the preparation and submission of 510(k)s, PMAs, IDEs, Technical Files, etc.
• 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; maintain databases as required
• Ensure the organization stays up-to-date on changes to requirements through regulatory intelligence monitoring
• Interface with our customers on regulatory issues
• Lead FDA interactions including in-person meetings, teleconferences, and other agency communications as needed

To be successful in this role, you will need the following skills and experience:

• BS in a technically related field
• Minimum of 5 years of direct work experience in a medical device regulatory role with demonstrated success in obtaining product approvals and clearances
• 510K experience
• Experience in medical device regulations including U.S. FDA Quality Systems Regulations (QSRs), ISO 13485, product registrations, UDI, product labeling, and EU MDR requirements
• Experience in direct FDA interactions including pre-market notifications, IDEs, Q-submissions and in-person meetings preferred
• RAC certification a plus
• Experience in drug, biologic and combination products a plus
• Experience in product development of medical devices a plus

About DEKA:

One 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 the same innovation and cutting-edge technology into the modern age.

Behind DEKA’s brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored.