Senior Regulatory Affairs Specialist
hace 1 día
Maidstone
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 exceptional regulatory expertise to help us bring innovative products to market, maintain compliance for existing products, and ensure our submissions, labeling, technical files, and product documentation meet global regulatory standards. Your Role\n We are on the lookout for a Senior Regulatory Affairs Specialist who will play a crucial role in supporting regulatory submissions, audits, inspections, technical documentation, and product lifecycle activities for medical devices. If you have a strong grasp of US, EU, and Canadian regulatory requirements 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, • Manage 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 ensure all documentation is current, accurate, and inspection-ready.\n, • Participate in internal and external audits, inspections, and investigations.\n, • Monitor 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\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 applicable 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, with the ability to make 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 with Microsoft Office and experience with regulatory databases or tracking systems.\n, • A college degree or technical bachelor’s degree, preferably 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. We are committed to making Hologic a destination for top talent. From day one, you will receive 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. Salary\n £40,000 – £50,000 gross per year. 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
Agricultura
