Regulatory Affairs Specialist
oxenham groupSaint Paul (MN)
About the role
Regulatory Affairs Specialist This role is ideal for a regulatory professional with strong experience in FDA, Health Canada, and EU medical device requirements. The Regulatory Affairs Specialist will maintain global registrations and technical documentation, support audits, manage product compliance throughout the lifecycle, and provide strategic regulatory input to cross-functional teams.
Key Responsibilities:
- Maintain and update European technical files, including risk assessments, usability reports, and clinical evaluations
- Prepare and execute annual regulatory registrations for the U.S. (FDA), Canada, and other global markets
- Assist international distributors with product registration and compliance requirements
- Review product changes to ensure ongoing regulatory conformity
- Evaluate product labeling, marketing content, and advertising materials for compliance
- Support and manage product recalls, adverse event reporting (MDR/Vigilance), and regulatory communications
- Lead and support regulatory audits and inspections by the FDA, Notified Bodies, and customers
- Prepare change notifications for submission to global regulatory authorities
- Draft, revise, and maintain SOPs related to regulatory processes
- Maintain regulatory certificates including the Certificate to Foreign Government (CFG)
- Respond to customer surveys, internal requests, and other ad hoc regulatory needs
- Collaborate with Quality, R&D, and Manufacturing to maintain compliance across the product lifecycle
- Other duties as assigned
Required Qualifications:
Bachelor's degree in a scientific, technical, or regulatory discipline
Minimum 3 years' experience in Regulatory Affairs within an FDA-registered and ISO-certified medical device company
Hands-on experience with:
- Technical files and global registrations
- Medical Device Reporting (MDR)
- Vigilance and recall management
- Change control and agency notifications
- Working knowledge of:
- FDA 21 CFR Part 820ISO 13485 Health Canada and European medical device regulations (including MDR)ISO 14971 and MDSAPStrong organizational and time-management skills with keen attention to detail
- Clear and professional written and verbal communication skills
- Able to work independently and take ownership of assigned responsibilities
- Familiarity with sterilization processes (EO and Gamma) is strongly preferred
- Proficiency with Microsoft Office Suite
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