Regulatory Affairs Manager

DEKA Research & Development has an immediate opening for a Regulatory Affairs Manager to contribute to a dynamic, medical device research and development and post-market surveillance environment. The individual in this high visibility role will have a direct impact on the success of the innovative life science devices that DEKA develops. The chosen candidate will support the implementation of regulatory strategies to deliver FDA approval or clearance as well as obtain the CE Mark and other international applications.

How you will make an impact:

• Prepare (including creating, collecting and coordinating) regulatory documentation in support of regulatory submissions such as 510(k)s, PMAs, IDEs, CE Technical Files, etc.
• Maintain Gudid database. Register new product UDIs in accordance with applicable requirements.
• Monitor and assess on-going product and labeling changes for continued compliance. Assess RA impact on proposed change controls.
• Prepare and submit manufacturer Medical Device Reports (FDA Form 3500A).
• Support continual improvement in regulatory processes to increase efficiency and maintain the highest levels of compliance.
• Be a resource for current knowledge of applicable regulations and requirements. 
• Advise on Regulatory submission strategy and participate in FDA regulatory meetings, teleconferences, and other Agency communications as needed.
• Represent Regulatory Affairs on R&D product development project teams to ensure all regulatory requirements are met throughout the development process.
• Act as Regulatory Affairs SME during audits (FDA, ISO, Supplier, Internal, etc.)
• Interface with our customers on regulatory issues.
• Develop and manage project timelines for regulatory submissions.

Skills needed to be successful:

• BS in a technically related field
• Minimum of 5 years direct work experience in a medical device Regulatory role
• Experience in Medical Device Regulations, including U.S. FDA Quality Systems Regulations (QSRs), ISO 13485, EU MDR, MDSAP, product registration and listing, UDI, product labeling, and CE Marking requirements a plus
• Previous management experience is preferred
• Experience and understanding of International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and FDA regulations
• Ability to meet deadlines and perform multiple tasks in a fast-paced setting

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 & 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.