Manager of Regulatory Affairs

EPM Scientific; Bothell (WA); Sur place; USD 100 000 - 130 000; Plein temps

Résumé du poste

A global diversified pharmaceutical company is seeking a Manager of Regulatory Affairs. This role involves developing regulatory strategies for medical devices with a focus on aesthetics. The ideal candidate will have a Bachelor's degree in life sciences and a minimum of 6 years' experience in regulatory affairs within a multinational medical device context. Responsibilities include preparing regulatory documentation, leading compliance efforts, and collaborating with cross-functional teams. This is an opportunity to significantly shape the future of healthcare.

Qualifications

• Minimum of 6 years' experience in regulatory affairs within a multinational medical device company.
• Deep understanding of international regulations for active medical devices.
• Proven experience preparing and submitting 510(k)s and Health Canada applications.

Responsabilités

• Develop and implement global regulatory strategies for medical device products.
• Lead the creation of regulatory plans and risk assessments.
• Prepare and submit regulatory documentation such as 510(k)s and EU MDR Technical Files.

Connaissances

Regulatory strategy development

Cross-functional collaboration

Stakeholder management

Regulatory inspections support

Formation

Bachelor's degree in life sciences or a technical discipline

Advanced degree

Description du poste

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.