What to expect:

• Prepare, coordinate, and compile document packages for regulatory submissions, audits, inspections, license renewals, and annual registrations.
• Support regulatory activities for new and mature medical device products, including product changes and ongoing compliance.
• Manage and maintain regulatory databases, technical files, and supporting documentation.
• Review technical data, reports, labeling, marketing materials, user manuals, and other product content for regulatory compliance.
• Support compliance with US, EU, Canadian, and international regulatory requirements.
• Manage labeling and unique device identification requirements.
• Provide regulatory input on design reviews, manufacturing changes, clinical protocols, and product approval strategies.
• Document regulatory decisions and ensure documentation remains current, accurate, and inspection-ready.
• Participate in internal and external audits, inspections, and investigations.
• Monitor evolving regulations, standards, and procedures, and translate changes into practical business guidance.
• Contribute to process, procedure, standard, and tracking/control system improvements.
• Partner with cross-functional teams to resolve regulatory issues and support timely product approvals.
• 
  

What we expect:

• Experience in the regulated medical device industry, ideally supporting product lifecycle and regulatory compliance activities.
• Hands-on experience with regulatory submissions, technical files, product documentation, audits, inspections, and investigations.
• Strong understanding of US FDA, EU, Canadian, ISO 13485, ISO 9001, and other applicable international regulatory requirements.
• Ability to review labeling, marketing materials, user manuals, technical documentation, and supporting data from a regulatory perspective.
• Strong technical writing, communication, interpersonal, and presentation skills.
• Good data and statistical analysis skills, with the ability to make informed recommendations.
• High attention to detail and strong judgment when evaluating regulatory issues and solutions.
• Confidence working cross-functionally with Regulatory Affairs, R&D, Clinical, Quality, Marketing, and global partners.
• Proficiency with Microsoft Office and confidence working with regulatory databases or tracking systems.
• A college degree or technical bachelor’s degree, preferably in a scientific, engineering, or related discipline.
• Regulatory Affairs Certification — RAC — or project management experience would be beneficia
•