Sr. Regulatory Affairs Specialist-Medical Device-Burlington, MA

Michael Page

  • Burlington, MA
  • $100,000-110,000 per year
  • Permanent
  • Full-time
  • 1 month ago
  • Apply easily
Dynamic role in fast growing Medical Device Start-up

Tremendous Flexibility to WFH

About Our Client

Our client is an oral health care company that delivers advanced, easy-to-use implants, biomaterials and planning software for dental professionals focused on providing the most functional and most aesthetically pleasing outcomes possible.

Job Description

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

Description

The key responsibilities of are:the Sr. Regulatory Affairs Specialist are:
  • Actively contribute to the development and implementation of regulatory strategy for assigned projects and programs.
  • Provide input to new product development team on regulatory strategy for new products and product improvements with a focus on US, Canada and EU markets
  • Prepare and submit 510K's, draft 510K letter to files, draft and update technical files)
  • Develop policies and procedures to ensure regulatory compliance for areas of responsibility.
The Successful Applicant

The successful Sr. Regulatory Affairs Specialist are:
  • BS Degree
  • 5+ years of Regulatory Experience
  • Experience with 510K Submissions(Preferably Worldwide)
  • Solid Knowledge of U.S., European, Canadian, and international regulatory processes
What's on Offer

Our client offers a base salary with strong benefits and the flexibility to work from home.

Contact:

Daniel Hall

Quote job ref: 1471804

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Sr. Regulatory Affairs Specialist-Burlington, MA

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Job summary

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Salary:USD100,000 - USD110,000

Consultant name:Daniel Hall

Job Reference:1471804

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