About this role
Regulatory Affairs Specialist - Coloplast A/S
Location
Minneapolis, MN, US
Country/Region: United States
The Regulatory Affairs Specialist is responsible for day-to-day regulatory affairs tasks required to maintain compliance with Coloplast’s quality system and applicable regulatory requirements. This position will also prepare, monitor, and communicate status of regulatory submissions and perform duties related to regulatory affairs post-market surveillance, change analysis, claims review, and vigilance reporting. This position is also responsible for design control compliance for assigned products and will support development and execution of regulatory strategies per timelines to ensure clearance / approval in the assigned geographies.
Major Areas of Accountability
- Support compilation of high-quality regulatory submissions for all products to expedite clearance/approval and sustain commercial availability for all products and support interactions with regulatory agencies.
- Participate on development project teams providing the team with information on applicable regulatory requirements.
- Support compilation of technical documentation to support CE-marking for assigned products.
- Support registration outside EU with appropriate documentation and maintain regulatory registrations and licenses.
- Review and approve change controls, supplier evaluations, and non-conforming material reports for potential impact on regulatory status. Prepare submissions, supplements, amendments, and letters to file as needed to do