Manager of Regulatory Affairs

Join a global, diversified pharmaceutical company committed to enriching lives through innovative healthcare solutions. We are seeking a Manager of Regulatory Affairs to drive regulatory strategy and execution for our medical device portfolio, with a focus on aesthetic technologies. This is an exciting opportunity to be part of a collaborative, forward-thinking team that actively shapes the future of healthcare. Responsibilities Develop and implement global regulatory strategies and roadmaps for assigned medical device products, informed by market dynamics, legislative trends, and product marketing goals. Serve as a core member of NPI (New Product Introduction) teams, ensuring regulatory requirements are proactively integrated throughout the development lifecycle Lead the creation of regulatory plans, risk assessments, and corrective actions to meet global compliance standards, including FDA clearance, Health Canada registration, CE Marking, and other international approvals. Prepare and submit regulatory documentation such as 510(k)s, EU MDR Technical Files, STEDs, and Health Canada dossiers. Review and approve Regulatory Affairs Assessments during NPI phases to ensure alignment with global strategy. Support and guide RA specialists managing global registrations, and monitor approval status across the product portfolio. Partner with cross-functional teams (R&D, QA, Supply Chain) to interpret and apply relevant regulations, standards, and guidance documents. Qualifications Bachelor's degree in life sciences or a technical discipline required; advanced degree preferred. Minimum of 6 years' experience in regulatory affairs within a multinational medical device company; experience with aesthetic devices is a plus. Deep understanding of international regulations for active medical devices, with emphasis on U.S., Canadian, EU MDR, and APAC markets. Proven experience preparing and submitting 510(k)s, Health Canada applications, and EU MDR documentation. Skilled in managing complex regulatory activities and engaging effectively with regulatory authorities. Strong stakeholder management and cross-functional collaboration skills. Experience supporting regulatory inspections and audits. #J-18808-Ljbffr EPM Scientific