Staff Regulatory Affairs

This role is responsible for managing global regulatory initiatives, working with third parties as appropriate. Build consensus while championing global regulatory initiatives for projects. Author global pre-market submissions, including 510(k)s and PMA supplements to the U.S. FDA in alignment with pre-market and post-market strategies. Create and manage Technical Files in compliance with IVDD and IVDR. Work with international colleagues on establishing design dossiers for their intended market for new product development and design changes. 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.

According to JobzMall, the average salary range for a Staff Regulatory Affairs in Building 1, 1000 Lake Hazeltine Dr, Chaska, MN 55318, USA is between $70,000 and $90,000 per year. This range is based on salary data from various employers who are hiring for this position in the area.

Beckman Coulter Inc., is a Danaher Corporation company that develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing.