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Senior Regulatory Affairs Specialist

  • LocationSaint Paul, MN 55127 - United States
  • Work TypeFull time
  • Positions1 Position
  • Published At:7 days ago
  • Job no: 38258
  • Category: Regulatory Affairs

Job Description

Our client, a leading medical device company, is currently seeking an accomplished Senior Regulatory Affairs Specialist to join the team. Here is an overview of the role:

1) Provide regulatory affairs support for component, contract and finish device manufacturing

2) Develop and execute on regulatory affairs plans to support product realization activities

3) Supervise complaint handling process and other post-market surveillance activities related to finished devices

4) Support global sites in maintaining ISO certifications and track correspondence from notified bodies

5) Submit a request for certificates from the FDA for International regulatory compliance and export requirements

6) Create and defend regulatory submissions and approvals

7) Maintain a safe and healthy work environment

8) Comply with the company’s policies and procedures

9) Perform other duties as assigned

Critical Requirements

1) Appropriate full-time work experience is mandatory (no students or fresh graduates please)

2) Recent experience in the medical device industry is strongly preferred

3) Preference will be given to candidates with recent experience in regulatory affairs

This role is a great opportunity for the right person looking to advance their career with a wonderful company. If you are qualified and think that you are a strong fit for this role, please apply ASAP!

Compensation and Other Details

Base Salary: Highly competitive package, commensurate with experience

  • Published on 22 Jul 2021, 5:01 AM