Sr. Regulatory Affairs Specialist
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.