Regulatory Affairs Manager

Position Overview We are seeking a Regulatory Affairs Manager to lead regulatory activities supporting the development, approval, and commercialization of Class III cardiovascular implantable devices and delivery systems. The role includes regulatory strategy, preparation and maintenance of submissions, regulatory change assessment, and ongoing compliance throughout the product lifecycle, in collaboration with internal teams and global regulatory stakeholders. Key Responsibilities ·        Develop and implement regulatory strategies for new products, product modifications, and market expansion. ·        Prepare, coordinate, and maintain regulatory submissions and technical documentation for the U.S., EU, and other international markets. ·        Manage interactions with regulatory authorities and notified bodies, including responses to questions and requests for additional information. ·        Assess the regulatory impact of design, manufacturing, material, supplier, labeling, and process changes. ·        Support the maintenance of U.S. PMA approvals, including applicable supplements, reports, and other post-approval obligations. ·        Maintain EU technical documentation and support conformity assessment activities under applicable European requirements. ·        Provide regulatory guidance to R&D, Engineering, Manufacturing, Quality, and Clinical teams. ·        Review labeling and promotional materials for consistency with approved indications and applicable requirements. ·        Coordinate regulatory inputs to post-market surveillance, vigilance, and safety reporting activities. ·        Monitor regulatory developments and assess their impact on products and business activities. ·        Maintain regulatory registrations, submission records, and approval timelines. ·        Collaborate with global regulatory teams to ensure alignment across markets. Required Qualifications ·        Bachelor’s degree in Engineering, Life Sciences, or a related discipline. ·        Proven experience in Regulatory Affairs within the medical device industry, including ownership of submissions and interactions with regulatory authorities. ·        Direct regulatory experience with Class III medical devices, preferably implantable products. ·        Strong working knowledge of U.S. FDA requirements and the EU Medical Device Regulation (MDR). ·        Hands-on experience preparing and maintaining regulatory submissions and technical documentation. ·        Experience assessing the regulatory impact of product and manufacturing changes. ·        Familiarity with ISO 13485, ISO 14971, and the relationship between regulatory requirements and quality system processes. ·        Strong project management skills, with the ability to coordinate multiple submissions and priorities. ·        Ability to interpret complex regulatory requirements and translate them into practical guidance. ·        Fluent English, with excellent technical writing and communication skills. Preferred Qualifications ·        Experience with cardiovascular implants, stent grafts, catheters, or delivery systems. ·        Experience with U.S. PMA submissions, supplements, and post-approval requirements. ·        Experience with EU conformity assessment for Class III implantable devices. ·        Familiarity with clinical evidence requirements, clinical evaluation, and post-market clinical follow-up. ·        Experience supporting regulatory activities for sterile devices. ·        Experience working within a global medical device organization.