Regulatory Affairs Coordinator

Regular Full-Time Scanlan International, Inc., St. Paul, MN, US

Salary Range: $20.00 To $32.00 Hourly

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 Coordinator to join our organization and continue this commitment.

The Regulatory Affairs Coordinator provides operational and administrative regulatory support for Scanlan products. The position focuses on reviewing and maintaining technical and regulatory documentation, managing regulatory listings and registrations, and completing routine compliance activities under a supervisor's direction. This role helps keep the company’s product registry accurate, current, and active in applicable markets while supporting ongoing baseline compliance with regulatory requirements.

This position is based out of our headquarters office, south of downtown St. Paul. We welcome an on-site work environment Monday through Friday. The ideal work hours for this position are 8:30AM – 5:00PM, but we are flexible. This position reports to the Director of Regulatory Affairs.

• Review, update, organize, and maintain technical and regulatory documentation in accordance with established procedures and supervisor direction.
• Verify that documents are complete, accurate, current, and filed in the appropriate controlled location.
• Collect information and coordinate routine document updates with Regulatory Affairs, Quality, Engineering, and other internal teams.
• Track document status, due dates, approvals, and outstanding information; communicate questions or delays to the supervisor.

• Maintain product, establishment, and market registration records for Class I and non-invasive Class IIa medical devices.
• Prepare routine listing, registration, renewal, and change-notification documentation using approved information and templates.
• Monitor renewal dates and submission status to help keep product registrations and listings active and current.
• Maintain, revise and upload UDI Databases, including GUDID, UDIMED, SWISSDAMED and AUSTRALIA MED.

• Maintain regulatory files, trackers, databases, certificates, and supporting records needed for baseline compliance.
• Complete routine checks of records and product information against established regulatory requirements and internal procedures.
• Support document collection and record updates associated with complaints, CAPA, post-market surveillance, audits, and regulatory requests.
• Escalate missing information, discrepancies, expiration risks, and potential compliance concerns to the supervisor.

• Prepare routine export certificates, supporting documentation, and records using approved information and templates.
• Maintain organized records supporting applicable FDA, U.S. Customs and Border Protection, and international market requirements.
• Provide other routine regulatory and administrative support as assigned by the supervisor.

• BS/BA degree in life sciences, other related coursework or professional training in medical device regulations, quality systems, clinical evaluation, or risk management is preferred.

• 0-2 years of administrative/coordinator experience
• Experience in healthcare, life sciences, medical devices, pharmaceuticals, biotechnology, or another regulated…