Regulatory Affairs Coordinator

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. What You’ll Do: Technical and Regulatory Document Management – 50% of the time 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. Regulatory Listings and Registrations – 20% of the time 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 AUSTRALIAMED. Routine Regulatory Compliance Support – 20% of the time 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. Import/Export and Administrative Regulatory Support – 10% of the time 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. The Experience, Skills and Abilities Needed: Education: High School degree. BS/BA degree preferred. 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. Experience : 0-2 years of administrative/coordinator experience Experience in healthcare, life sciences, medical devices, pharmaceuticals, biotechnology, or another regulated industry is preferred. Familiarity with FDA requirements, international medical device regulations, and document control practices is preferred. Skills : Basic written communication, reading comprehension, and attention to detail. Ability to review and update techn…

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