Regulatory Affairs Specialist

About This Role

This Regulatory Affairs Coordinator III role independently supports and executes regulatory activities for U.S. Class II and EU Class II and/or Class III medical devices throughout their product lifecycle. The position is responsible for preparing and maintaining regulatory submissions and technical documentation, supporting compliance with FDA and EU MDR requirements, and collaborating with cross-functional teams to support regulatory objectives.

Responsibilities

• Prepare, review, maintain, and support regulatory submissions and technical documentation for medical devices in U.S. and international markets
• Support regulatory compliance activities for Class II and Class III medical devices in accordance with FDA regulations and EU MDR requirements
• Maintain and update EU MDR technical files and related regulatory documentation
• Collaborate with cross-functional teams including Quality, Engineering, Clinical, Manufacturing, and Marketing to support product lifecycle activities
• Monitor and interpret applicable global regulatory requirements and communicate updates to relevant stakeholders
• Support product registrations, renewals, amendments, and change control activities
• Ensure documentation accuracy, completeness, and compliance within document management systems
• Participate in internal and external audits and regulatory inspections as needed
• Assist with regulatory strategy execution for new products, product modifications, and sustaining activities
• Prioritize and manage multiple assignments in a fast-paced environment while meeting project timelines

Requirements

• Bachelor

’s degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related field

• 5–7 years of Regulatory Affairs experience within the medical device industry
• Direct experience supporting U.S. Class II medical devices and EU Class II and/or Class III medical devices
• Hands-on experience supporting EU MDR technical files and related documentation
• Knowledge and understanding of global regulations relevant to medical devices
• Experience preparing and maintaining regulatory submissions and technical documentation
• Proficiency with Microsoft Office applications and document management systems
• Strong written and verbal communication skills
• Strong organizational, analytical, and critical thinking skills
• Ability to manage competing priorities and work independently with limited supervision
• Ability to collaborate effectively within cross-functional and interdepartmental teams
• Must be authorized to work in the United States without current or future employer sponsorship