Principal Regulatory Affairs Specialist

To support product development and compliance activities, the full-time Principal Regulatory Affairs Specialist will manage regulatory strategies, prepare global submissions, and collaborate with cross-functional teams while working remotely. Key responsibilities: Provide guidance to cross-functional partners and junior regulatory affairs staff Monitor new and changing regulations, assess business impact, and recommend appropriate actions Prepare and submit global regulatory applications while maintaining complete regulatory files and product registrations Required qualifications: Bachelor's degree in a scientific or technical discipline Minimum of 7 years' experience in Regulatory Affairs within the medical device industry Demonstrated experience with regulatory requirements for implantable or active implantable medical devices Experience preparing regulatory submissions for medical devices Strong understanding of FDA regulations, EU MDR, and international regulatory frameworks