Senior Regulatory Affairs Specialist

Our client, a leading medical devices manufacturing company, is looking for a Senior Regulatory Affairs Specialist. This is for an initial duration of 18 months and is located in Chaska, MN.

Job Type: Contract (Candidates must be able to work on W2 without VISA sponsorship)

3 must haves:

Experience with design changes,

demonstrated RA leadership on high visibility core team,

IVDR or EMDR experience

Job Description:

The Senior Specialist Regulatory Affairs is an individual contributor and subject-matter-expert responsible for creating and executing regulatory strategies for pre-market and post-market activities.

Primary responsibilities include evaluation, coordination, preparation and implementation of post-market regulatory activities and design change evaluations.

Additionally, this position supports regulatory strategy for new product development activities and applicable submissions or registrations.

This position is in the Immunoassay Regulatory Affairs team and reports to the Manager of Regulatory Affairs.

This role is responsible for managing regulatory initiatives and working with third parties as appropriate.

Build consensus while championing global regulatory initiatives for projects.

This position will lead and support change to legal manufacturer designation for the products.

In this role, you will have the opportunity to:

Manage IVDR Technical Files in compliance

Advise business teams to consider the impact of current or emerging regulatory issues, works with colleagues globally to facilitate and ensure company practices are consistent with the corporate regulatory risk posture.

Ensure sound post-market product regulatory strategies including minimizing the risk of negative post-market submissions needed for design changes, such as agency review delays.

The essential requirements of the job include

Bachelor's Degree with 5+ years of experience in Life Sciences or a Master's Degree with 3+ Years of experience in Life Sciences or Doctorate with 0-2 years of experience in Life Sciences

Subject matter expertise in registration and commercialization of medical devices

Demonstrated experience leading design change teams for RA.

This is also a plus:

Demonstrated knowledge and understanding of regulations and guidelines governing in-vitro diagnostics.

RAC certificate

Strong FDA, Health Canada, and EU submission experience