Senior Regulatory Affairs Specialist
13 days ago
Cambridge
Join Our Team as a Senior Regulatory Affairs Specialist!\n At Hologic, we are dedicated to enabling healthier lives everywhere, every day. To achieve this mission, we need talented individuals with strong regulatory expertise to help us bring innovative products to market, maintain compliance, and ensure our documentation meets global regulatory standards. \n We are on the lookout for a Senior Regulatory Affairs Specialist to support our regulatory submissions, audits, inspections, technical documentation, and product lifecycle activities for medical devices. If you have a solid understanding of US, EU, and Canadian regulations and enjoy collaborating with cross-functional teams, this role is perfect for you! What You'll Do:\n\n • Prepare, coordinate, and compile document packages for regulatory submissions, audits, inspections, license renewals, and annual registrations.\n, • Support regulatory activities for both new and mature medical device products, including product changes and ongoing compliance.\n, • Manage and maintain regulatory databases, technical files, and supporting documentation.\n, • Review technical data, reports, labeling, marketing materials, user manuals, and other product content for regulatory compliance.\n, • Ensure compliance with US, EU, Canadian, and international regulatory requirements.\n, • Oversee labeling and unique device identification requirements.\n, • Provide regulatory input on design reviews, manufacturing changes, clinical protocols, and product approval strategies.\n, • Document regulatory decisions and keep documentation current, accurate, and inspection-ready.\n, • Participate in internal and external audits, inspections, and investigations.\n, • Stay updated on evolving regulations, standards, and procedures, translating changes into practical business guidance.\n, • Contribute to improvements in processes, procedures, standards, and tracking/control systems.\n, • Collaborate with cross-functional teams to resolve regulatory issues and support timely product approvals.\nWhat We Expect From You:\n\n, • Experience in the regulated medical device industry, particularly in product lifecycle and regulatory compliance activities.\n, • Hands-on experience with regulatory submissions, technical files, product documentation, audits, inspections, and investigations.\n, • Strong understanding of US FDA, EU, Canadian, ISO 13485, ISO 9001, and other relevant international regulatory requirements.\n, • Ability to review labeling, marketing materials, user manuals, technical documentation, and supporting data from a regulatory perspective.\n, • Excellent technical writing, communication, interpersonal, and presentation skills.\n, • Strong data and statistical analysis skills, enabling informed recommendations.\n, • High attention to detail and sound judgment when evaluating regulatory issues and solutions.\n, • Confidence in working cross-functionally with Regulatory Affairs, R&D, Clinical, Quality, Marketing, and global partners.\n, • Proficiency in Microsoft Office and familiarity with regulatory databases or tracking systems.\n, • A college degree or technical bachelor’s degree in a scientific, engineering, or related discipline.\n, • Regulatory Affairs Certification (RAC) or project management experience is a plus.\nWhy Join Hologic?\n At Hologic, your work has purpose. You will be part of a company focused on improving health through innovation, quality, and regulatory excellence. \n We are committed to making Hologic a destination for top talent. From day one, we provide comprehensive training, ongoing development, and the tools you need to succeed and grow your career. \n If you are a regulatory affairs professional who thrives on technical documentation, submissions, cross-functional collaboration, and supporting products throughout their lifecycle, we would love to hear from you! \n Apply today and help us enable healthier lives everywhere, every day! \n Salary: £40,000 – £50,000 gross per year \n The final offer will depend on experience, skills, and alignment with internal pay structures. We also offer a comprehensive benefits package, including pension and insurances. \n #LI-RH1