Regulatory Affairs Specialist
Job Posting for Regulatory Affairs Specialist at DEKA Research & Development
DEKA employs a team of over six hundred professionals, whose engineering, design, manufacturing and quality expertise make DEKA a hot spot for creating innovative solutions and advanced technologies. Located about an hour from Boston, the beach, and the mountains, DEKA is one of the leading research and development companies in the country and is the birthplace of some of the most innovative and life-changing products of our time.
DEKA Research & Development has an immediate opening for a Regulatory Affairs Specialist to work in a dynamic, medical device research and development environment. The individual in this high visibility role will have a direct impact on the success of the innovative devices that DEKA develops. He or she will formulate and execute regulatory strategies resulting in FDA clearance in the U.S. as well as the CE Mark on international applications.
What you will do:
- Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies such as 510(k)s, PMAs, IDEs, CE Technical Files, etc.
- 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
- Interface with our customers on matters of a regulatory nature
What you need:
- BS in a technically related field
- Minimum of 2 years direct work experience in a regulatory role
- Experience in U.S. Medical Device Regulations, including Quality Systems Regulations (QSRs), ISO 13485, Establishment registration, UDI labeling, and CE Marking requirements a plus
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Job openings at DEKA Research & Development
Manchester, NH
Full Time
Manchester, NH
Full Time
Manchester, NH
Full Time
Manchester, NH
Full Time
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