Senior Regulatory Affairs Specialist

Sr. Regulatory Affairs Spec (Through end of April 2025 // Mounds View, MN):

HM's Top Needs:

1. Post-market changes, regulatory assessment experience
2. 30 day Notices, Annual Report memo authoring, RTR submissions and site transfer submission experience
3. Able to work well and collaborate cross functionally to complete change management activities

Education Required: Bachelor’s degree in Scientific discipline, Preference for a Masters in Regulatory Affairs

Years’ Experience Required: 5 years in medical device Regulatory Affairs

Duties:

• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
• Leads or compiles all materials required in submissions, license renewal and annual registrations.
• Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
• Monitors and improves tracking / control systems.
• Keeps abreast of regulatory procedures and changes.
• May direct interaction with regulatory agencies on defined matters.
• Recommends strategies for earliest possible approvals of clinical trials applications.

Required Knowledge and Experience:

• Requires a University Degree and minimum of 4-6+ years of relevant experience