Sr. Regulatory Affairs Specialist

Location: Eagan, Minnesota, USA
Salary: competitive
Job Type: Contract
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Role: Regulatory Affairs Specialist

Location: Eagan, MN (Open to Remote)

Employment: 6 month contract to hire

Day to Day:

  • There are no boring days and would be working cross functionally to makes sure the job is done
  • Will be working in an emerging markets in the AU, EU, and US
  • Communicating with team members over sea
  • Provide direction on application of external standards for all projects as required. Execute global product submission strategies as directed.
  • Provide leadership and direction to the executive team on the regulatory impact of product and process changes.
  • Lead regulatory activities for product field corrective actions to maintain compliance and ensure that product approvals are properly maintained and product re-submissions are properly managed.
  • Assist in the development and implementation of required post-market surveillance
  • Review Engineering Change Requests (ECRs) for global regulatory impact.
  • Author, review, and/or approve internal operating procedures related to regulatory affairs.

Must Haves (Be As Specific As Possible):

  • Minimum of 5-10+ years' experience as a Regulatory Affairs Specialist
  • Experience working in US and/or EU MDR
  • Ability to work cross functionally
  • Knowledgeable of working an emerging market
  • Experience with Cardio Vascular, Medical Device Class lll

Preferred candidate will also have:

  • Experience working in the Australia Market (TGA)
  • Experience in working in a small company environment
  • RAC Certification

Sthree US is acting as an Employment Business in relation to this vacancy.

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