Regulatory Affairs Project Manager

POSTED ON 6/25/2020 AVAILABLE BEFORE 9/21/2020
DEKA Research & Development Hired Organization Address Manchester, NH Full Time

Job Posting for Regulatory Affairs Project Manager 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 Project Manager 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.

How you will make a difference:

  • Prepare and submit regulatory applications such as 510(k)s, PMAs, IDEs, etc.
  • Participate in and lead FDA regulatory meetings, teleconferences, and other Agency communications as needed
  • Interface with our customers on matters of a regulatory nature
  • Participate in the design and conduct of clinical trials, and assist in obtaining the appropriate regulatory approvals from the FDA, IRBs and/or Ethics Boards

What we are looking for:

  • BS in a technically related field
  • Minimum of 5 years direct work experience in a regulatory role and a demonstrated success in organizing and conducting FDA meetings and filing regulatory submissions
  • Experience in U.S. Medical Device Regulations, including Quality Systems Regulations (QSRs), ISO 13485, Establishment registration, UDI labeling, and CE Marking requirements

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