Regulatory Affairs Advisor - Cambridge, Massachusetts United States - 18323

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JOB DESCRIPTION

Job #: 18323
Title: Regulatory Affairs Advisor
Job Location: Cambridge, Massachusetts - United States
Employment Type:
Salary: $130,000.00 - $140,000.00 - US Dollars - Yearly
Other Compensation: Base + bonus, health insurance, dental, 401k, profit sharing
Employer Will Recruit From: Local
Relocation Paid?: NO

WHY IS THIS A GREAT OPPORTUNITY?


Our client, a leading provider of consumer, B2B and industrial digital imaging solutions are looking for a Regulatory Affairs Advisor to join their team in their Cambridge, MA office.

JOB DESCRIPTION

 

  • Develop regulatory plans and assessments for new products and design changes
  • Prepare or direct regulatory submissions for product approval including 510(k)s
  • Interact with regulatory agencies needed to obtain product approval.
  • Work collaboratively with core development teams, assisting with regulatory assessments and planning
  • Review labeling, training, and promotional materials for compliance with claims and applicable regulations

QUALIFICATIONS

  • 5+ years experience working in the Medical Device regulatory field, including experience working with 510(k) submissions
  • Experience working and liaising with regulatory agencies
  • RAC certification is a big plus