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International Regulatory Affairs Project Manager

DEKA Research & Development
Manchester, NH
  • Posted: over a month ago
  • Full-Time
Job Description

DEKA Research & Development has an immediate opening for an International Regulatory Affairs Project Manager to join our team focused on EU MDR compliance and international regulatory registrations and approvals. The individual in this high visibility role will formulate and execute regulatory strategies to deliver technical file dossiers that enable EU MDR compliance as well as support development team objectives for additional international approvals.

How you will make a difference:

  • Work in close association with customers and development teams to define and execute EU MDR compliance programs, including establishing regulatory requirements for Technical Files and leading the preparation and submission of dossiers and post-market surveillance reports
  • Lead Notified Body (NB) interactions including in-person meetings, teleconferences, and other NB communications as needed to support regulatory approvals
  • Participate in the design and conduct of clinical trials in support of EU MDR Clinical Evaluation Reports (CERs) and assist in obtaining and maintaining the appropriate research approvals from the FDA, IRBs and/or Ethics Boards
  • Support development teams as necessary to achieve 510(k) clearance, PMA and IDE approvals and international registrations per program objectives
  • Establish and continually improve international regulatory processes and procedures to increase efficiency and reduce time to market while maintaining the highest levels of compliance
  • Insure the organization stays up to date on global regulatory changes to requirements through monitoring regulatory authority and industry resources
  • Coach and mentor internal and external partners on effective regulatory strategies and tactics
  • Interface with our customers on regulatory issues

Skills we are looking for:

  • BS in a technically related field
  • Minimum of 5 years direct work experience in a medical device regulatory role with demonstrated success in obtaining product approvals/clearances
  • Experience in direct Notified Body interactions including MDD - EU MDR transitions, Technical Files for Class IIa, IIb and III devices, CER preparation and post-market reporting
  • Experience in U.S. and international medical device regulations including Quality Systems Regulations (QSRs), ISO and IEC standards, China, Japan and Brazil registration processes, UDI and product labeling requirements
  • MS in Regulatory Affairs a plus
  • RAC certification 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.

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DEKA Research & Development

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Manchester, NH
03101 USA

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Government

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