Regulatory Affairs Contractor

• Support regulatory activities associated with integration of medical device products and portfolios into existing business processes and systems
• Develop, update, and maintain Global Regulatory Plans (GRPs) and associated regulatory documentation
• Support global product registrations, renewals, license maintenance, and other market-specific regulatory requirements
• Assess regulatory impact of product, manufacturing, labelling, supplier, site, and quality system changes
• Support regulatory activities associated with legal manufacturer, manufacturing site, and quality system transitions
• Coordinate with regional Regulatory Affairs teams to identify country-specific requirements and execute regulatory actions necessary to maintain market access
• Support EU MDR and other global regulatory lifecycle activities, including technical documentation updates, assessments, submissions, and notifications
• Review existing regulatory documentation, identify gaps, and coordinate actions required to support integration and ongoing compliance
• Maintain regulatory trackers, plans, and deliverables and ensure activities are completed according to established timelines
• Partner with Quality, Operations, R&D, Clinical, Supply Chain, and other cross-functional stakeholders to support integration activities
• Identify and escalate regulatory risks, dependencies, and potential impacts to business or integration timelines

• Bachelor’s degree in life sciences, engineering, Regulatory Affairs, or a related discipline
• 3–5+ years of medical device Regulatory Affairs experience preferred
• Experience with global medical device registrations and lifecycle management
• Working knowledge of FDA medical device requirements and EU MDR
• Experience with additional international markets preferred
• Experience with regulatory change assessments, global regulatory planning, and/or business or product integration activities preferred
• Ability to independently manage multiple regulatory deliverables and collaborate effectively across global teams
• Strong organizational, written communication, and problem-solving skills
• Experience with Class II/III medical devices, global regulatory plans, EU MDR, regulatory change assessments, and integration or transition of established medical device portfolios is highly desirable
• Successful completion of employment verification and background checks
• Employment verification confirming job titles and dates of employment with two previous employers

• Competitive compensation paid in USD
• 20 days of paid time off (PTO) per year
• Opportunities for professional growth and career development
• Company-provided equipment
• A collaborative, inclusive, and multicultural work environment
• The opportunity to contribute to meaningful projects alongside a talented and supportive team