Regulatory Affairs Coordinator

Scanlan Int'l•St. Paul, MN

16h•Onsite

About The Position

Scanlan International, Inc., a medical device company specializing in surgical instruments, is seeking a Regulatory Affairs Coordinator to provide operational and administrative regulatory support. This position focuses on reviewing and maintaining technical and regulatory documentation, managing regulatory listings and registrations, and completing routine compliance activities under supervision. The role ensures the company’s product registry is accurate, current, and active in applicable markets while supporting ongoing baseline compliance with regulatory requirements. This position is based at the company's headquarters south of downtown St. Paul.

Requirements

High School degree.
0-2 years of administrative/coordinator experience
Basic written communication, reading comprehension, and attention to detail.
Ability to review and update technical documentation accurately in accordance with established procedures and supervisor direction.
Basic proficiency with Microsoft Office applications and file management (MS Word, Excel)
Ability to maintain organized records, follow instructions, manage assigned tasks, and protect confidential information.
Ability to communicate questions, issues, and task status to the supervisor and work cooperatively with team members.
U.S. Work Authorization & Sponsorship: Scanlan International will not offer sponsorship or take over sponsorship of an employment visa for this position.

Nice To Haves

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 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.

Responsibilities

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 AUSTRALIAMED.
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.

Benefits

Medical, Dental, and Vision Insurance
Group Life Insurance
Short-Term Disability Insurance
Long-Term Disability Insurance
401(k) Plan with Company Match
Workers' Compensation
Employee Assistance Program (EAP)
Regular Part-Time Benefit Eligibility
Training and Development Program
Tuition Assistance Program
Paid Time Off, including holidays, floating holidays, vacation, and earned sick and safe time (ESST)