Regulatory Affairs Advisor - Cambridge, Massachusetts United States - 18323



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

APPLY NOW FOR THIS JOB

Our recruiters are currently seeking to fill this position and hundreds like this in our network. If you are a match you'll be contacted with additional details.

We value your privacy and will never share your information with any employer without your consent.

Send your profile and resume to the recruiter who posted this job. You may include a cover letter to introduce yourself.

Cover Letter Text:

5,000 character limit