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Director of Regulatory and Clinical Affairs

DEKA Research & Development has an immediate opening for a Director of Regulatory and Clinical Affairs to work in a dynamic medical device R&D environment. This senior management position reports directly to the company President.

 

This high visibility role will have a significant and direct impact on the success of the various innovative projects that DEKA is currently developing.

The ideal candidate will initiate and conduct FDA meetings, teleconferences, and other Agency communications as needed. As the senior regulatory person, this individual will be the primary regulatory liaison between DEKA and our customers on matters of a regulatory and/or clinical nature. The Director of Regulatory and Clinical Affairs will also manage and oversee the design and conduct of clinical trials as well as assist in obtaining the appropriate regulatory approvals to conduct clinical studies from FDA, IRBs and/or Ethics Boards.  

Responsibilities:

  • Managing the regulatory/clinical department,
  • Directing the strategic planning for the US and Global regulatory effort,
  • Spearheading regulatory planning and obtaining regulatory approvals in the US, the CE mark on applicable international applications, and working with other non-CE countries’ regulatory authorities as needed.
  • Implementing regulatory plans,
  • Preparing and submitting regulatory applications, including 510(k)s, PMAs, IDEs, CE applications, etc.

Requirements:

  • Candidates must have a minimum of 10 years’ direct work experience in a lead regulatory role and demonstrated success in obtaining regulatory approvals.
  • Candidates must have, at minimum, a BS degree in a technically related field.
  • Prior experience in US medical device regulations,
  • Knowledge of FDA’s Quality System Regulations (QSRs),
  • International medical device experience,
  • Device CE marking requirements, and associated experience is desired.
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