Regulatory Affairs Manager

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Regulatory Affairs Manager

The company: leveraging machine learning to develop new cancer diagnostic tools.

The culture: amazing (this will probably be the best company you’ve ever worked at)

The bar: very high

The location: Boston

We’re looking for a regulatory affairs professional with at least 5 years experience, with significant exposure to software development, as related to medical device regulations. Particular experience with SaMD (Software as a Medical Device) is highly preferred but may not be necessary if you are an overachiever for all the right reasons. RAC certification is preferred, but experience learned from both success and failure is paramount. In this position, you’ll have the opportunity to contribute to growing the team and to developing your own challenging and rewarding career path. A general overview of responsibilities includes:

  • Completing FDA pre-submissions requests
  • Completing submissions (510(k)s, PMAs, PMA supplements), by building the technical files as well as the design dossiers and authoring summaries
  • Contributing to regulatory strategy for medical device compliance
  • Staying informed regarding new guidelines and regulations for successful implementation in the QMS
  • Reviewing and improving the QMS based on FDA QSR and the harmonized standards ISO 13485, ISO 62304, ISO 62366 and ISO 14971
  • Serving as the resident expert and contributing to important decisions being made in engineering, manufacturing, and clinical throughout the design control process; offering regulatory expertise during design input & output creation, verification, validation, design transfer, pre-clinical, and clinical testing

Requirements:

  • Minimum bachelor’s degree in an appropriate scientific or other related field
  • At least 5 years experience in a regulatory environment involving Software driven medical devices or the design of Software as a Medical Device (SaMD) technologies.
  • Ability to work autonomously to problem-solve, demonstrates excellent analytical skills
  • Knowledge and practical understanding of ICH Guidelines regarding GxP, as well as MDDR and IVDR
  • Experience in cross-functional project management in a regulated industry, especially in discussing controversial topics such as device risk, device classification, including MDDS, and human factors studies

Please apply directly to Margot@agilesearchinc.com

Mar, 26, 2019

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