Director, Regulatory Lead - Medical Device - Bioelectronics (all genders)

Job description

Join our team as Director, Regulatory Lead – Medical Device – Bioelectronics and drive global regulatory strategy for innovative implantable neurostimulation devices. Lead submissions, engage health authorities, and shape regulatory pathways for cutting-edge medical technology. Make a global impact in healthcare with a diverse, collaborative team at the forefront of bioelectronics innovation. Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to... Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to en... eu medical device regulation (eu-mdr) compliance, neurostimulation / bioelectronics device

expertise, combination product regulatory strategy, global regulatory strategy development (medical devices), cross-functional stakeholder management in matrixed organizations, estar process knowledge, ide / 510(k) / pma submission management, active implantable medical device regulation (class iii / aimd), 21 cfr part 820 quality system regulation, iso 13485 quality management systems, iso 14155 clinical investigation standards