Regulatory Affairs Specialist

Job Description

Job Description

Scanlan International, Inc., is a medical device company specializing in the highest-quality surgical instruments. Now in our fourth generation, the Scanlan family continues its dedication to providing the best surgical instrumentation available anywhere in the world. We are seeking a Regulatory Affairs Specialist to join our organization and continue this commitment.

The Regulatory Affairs Specialist will assist in maintaining market authorizations for Scanlan products, including design files, technical documentation, product registrations and listings. They will also assist with post-market surveillance and post-delivery regulatory activities necessary to ensure Scanlan products remain state-of-the-art for worldwide markets.

This position is based out of our headquarters office, south of downtown St. Paul. We welcome an on-site work environment Monday through Friday.

What You’ll Do As a Regulatory Affairs Specialist:

30% of your time will be spent assisting with the following Market Authorization

• US FDA Registrations/Listings
• Canada Medical Device Licenses
• EU product registrations
• Rest of World product registrations
• Maintain product submissions
• Maintain CE certification
• Maintain CFGs
• Maintain D of Cs
• Maintain Product Lists

30% of your time will be spent working with Post-Market Surveillance

• Update design files, technical files, risk files, and other technical documentation based post-market surveillance data and trends.

30% of your time assisting with Post Delivery Activities

• CAPA and Complaint investigations and record keeping
• Product return coordination for complaint investigations