Regulatory Affairs Professional

Job description

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. This is a role well suited to an ambitious professional, looking for the next step in their career. This is a hybrid role based in Walpole, MA. As a Regulatory Affairs Professional, you will be responsible for: Prepare, submit, and maintain regulatory submissions and lifecycle documentation, including FDA PMA Annual Reports, PMA 30‑day notices and supplements, 510(k) submissions and notes to file, IVDR Class D recertifications, significant change notifications, and other regulatory applications as required. Serve as a Regulatory Affairs subject matter expert, providing guidance to design control activities and new product development teams. Prepare, submit, and maintain Technical Files in compliance with applicable regulatory requirements and the Quality Management System (QMS). Collaborate with cross‑functional...