Skip to main content

This job has expired

Regulatory Affairs Specialist

Employer
Entegee
Location
Racine
Salary
Competitive

View more

Requirements:
  • Minimum of 3-5 years of experience in regulatory affairs within the medical device/biotech/pharma industry required
  • Knowledge on FDA Medical Device Reporting, Adverse Event, Recall and Fields Safety Correction Action (FSCA).
  • Must pass 4 panel drug test (no marijuana tested)

  • Additional Preferred Requirements:
  • Working knowledge of FDA medical device regulation, guidance documents, international standards (ISO 13485, ISO 14971), CE Mark required, EU MDD/MDR (Medical Device Regulations 2017/745EUMDR) preferred
  • Medical Device is preferred.

  • Job Description:
    As a Regulatory Affairs Specialist you will focus on providing regulatory support for new product development projects and maintaining continued market access of our existing product portfolio. The ideal candidate will be energetic, possess a strong regulatory background and performs well independently and as part of a team.

    Equal Opportunity Employer/Veterans/Disabled

    To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to

    The Company will consider qualified applicants with arrest and conviction records

    Get job alerts

    Create a job alert and receive personalized job recommendations straight to your inbox.

    Create alert