Principal Regulatory Affairs opening for direct hire opportunity with a medical device company in Plymouth, MN.
As the Principal Regulatory Affairs Specialist you will be focused on authoring 510Ks and EU design dossiers.
Technical competency in these areas is very important but the hiring manager's #1 focus is culture. They have a strong collaborative team and wants to continue with adding a team player to the RA group.
- Support product development teams for new and sustaining projects.
- Prepare US and OUS regulatory submissions required for approval or registrations, including 510(k)s, Memos to 510(k) files, Technical Files and Design Dossier.
- Prepare responses to FDA letters, supplements, and amendments.
- Review and approve product and process changes and labeling materials according to regulations.
- Write Standard Operating Procedures (SOPs) as needed to comply with the regulations.
- Review of documentation, protocols and reports received; and prepares additional written materials as needed.
- Bachelor's Degree in a scientific or engineering discipline
- 4 years of Regulatory Affairs experience in the medical device industry
- Experience authoring 510K submissions and design dossiers
- Experience with class II and/or III devices
Salary is up to $120K base salary + bonus
Flexible working environment
Sthree US is acting as an Employment Agency in relation to this vacancy.