Role details

Regulatory Affairs Specialist - Life Sciences

Franklin   •   USD70,000 - USD90,000   •  Permanent

Bullet points

  • Growing life science company
  • Experience in life sciences regulatory affairs required

About Our Client

Michael Page is partnering with a growing life sciences company west of Boston looking to hire a Regulatory Affairs specialist. This is an opportunity to join a growing team within a highly transparent and employee centric organization.

Job Description

The Regulatory Affairs specialist will:

  • Manage FDA, ISO 9001, ISO 13485, USDA, CMDCAS/MDSAP, REACH/RoHS compliance
  • Support New Product Development by evaluating and advising on pathway for regulatory compliance
  • Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies, including managing the process for 510(k) clearance for new products and technical file preparation for CE marking
  • Maintain regulatory registrations, perform annual technical file reviews/updates, and notify regulatory agencies of changes as appropriate (FDA, ISO, CMDCAS/MDSAP, USDA)
  • Maintain a current library of external standards to which the company complies, evaluate the impact of changes of external standards to quality systems through gap analysis, and implement required changes

The Successful Applicant

The Regulatory Affairs specialist will:

  • Bachelor's Degree in a scientific discipline
  • 5 years in a Life Science, cGMP/ISO environment in a regulatory affairs role, with direct experience in a Medical Device environment or IVD experience required
  • Working knowledge of FDA QSR/cGMP regulations as well as ISO 9001 and/or ISO 13485 required
  • Class II device experience desired
  • Experience in preparation and submission of FDA 510(k)s preferred

What's on Offer

  • Great career progression
  • Competitive compensation
  • Transparent and collaborative company environment

Apply for this job

Click the Apply or LinkedIn button below or contact Morgan Bernstein quoting job reference 1202715
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