Senior Regulatory Affairs Specialist - Marlborough, MA

IPG Medical Corporation is focused on developing next-generation medical products based on its state-of-the-art technology. Headquartered in Marlborough, MA, we aspire to work together with our employees and customers to apply light in ways that improve life.

Our mission is to develop innovative medical device laser solutions that make the world a better place. To accomplish this mission, we are committed to attracting and retaining the best talent and an engaged and thriving workforce that drives a sustainable future for our company and society.

Working at IPG Medical Group you can expect challenging projects, a motivating and friendly environment, and competitive benefits.

Please note, position will focus on registrations outside of the US.

• Prepare and submit global regulatory applications, in countries such as Japan, India, China, Saudi Arabia, Australia, Mexico and Brazil. Support U.S. Medical submissions (Pre-Submissions, 510ks, IDEs and applicable supplements and annual reports) and EU MDR Submissions.
• Review device labeling (including IFU) and advertising materials for compliance with global regulations; analyze and recommends appropriate changes.
• Assess design and manufacturing changes for compliance with applicable regulations and effect on global registrations
• Maintain regulatory files and tracking databases as needed.
• Support quality system audits by notified bodies, government agencies and customers.
• Obtain Medical Device Certificates to Foreign Government (CFGs)
• Support post market surveillance, including preparation of post market clinical follow up plans and reports. Participate in the review of complaints and all other post market-release feedback.
• Submit medical device reports. Support Unique Device Identifier activities.

• 5-10 years of experience with global regulatory submissions and management of Class II electro-mechanical medical devices
• Regulatory affairs experience in generating applications and experience in collaboration with internal and external partners to answer any subsequent questions.
• Knowledge of Design Controls and Risk Management practices, regulations and standards, such as FDA QSR's, ISO 13485, ISO 14971, IEC 60601, 60825, and 62366
• Experience with lasers and optical technologies desired, but not necessary
• Strong working knowledge of Microsoft Word and Excel

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