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Regulatory Affairs Consultant


  Woburn, Massachusetts   $110,000 - $130,000

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  Regulatory Affairs    Permanent

This is an opportunity to join a highly successful established consultancy located just north of the Boston MedTech hub. This organisation have been providing pragmatic and efficient solutions to clients for over two decades, with their Regulatory & Clinical services highly sought after across the Medical Device and IVD space.

Responsibilities:

  • The highly respected and versatile leadership team gives mentoring and learning opportunities like no other organisation currently in a recruitment drive.
  • Provide high level work in line with preparing clients for the revised MDR deadline of May 2021 and work closely with senior stakeholders.
  • To write and construct technical documentation/files and design dossiers in support of CE marking, 510(k), or similar approval processes.
  • Activities will include strategy planning, reviewing, and/or developing technical files, clinical evaluations, and quality management systems.
  • Working with clients looking to streamline their EUA regulatory pathway for COVID-19 essential products.

Experience required:

  • At least 3 years' prior Regulatory Affairs experience in the Medical Devices, IVD, or Biotech industries.
  • Bachelor's in a Life Sciences field is desirable.
  • Proven track record of working to tight deadlines and working on multiple projects. 
  • Understanding of U.S. Food and Drug Administration (FDA) laws and guidance.
  • Understanding of Health Canada Licensing Requirements and the EU IVDR.

We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.

Callum.Sparkes

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