Manager of Regulatory Affairs
Title: Regulatory Affairs Manager
Summary:
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.
The Manager will be responsible for…
- 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 life-cycle
- 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.
The Manager will have the following 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.
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