Senior Manager, Regulatory Affairs

Leading global regulatory strategy and compliance for a medical imaging portfolio, the full-time Senior Manager, Regulatory Affairs will drive regulatory excellence across the software product lifecycle, including market access strategies, cybersecurity considerations, and post-market obligations, all while working remotely. Key responsibilities Provides expert guidance on regulations and develops global regulatory strategies for medical devices and imaging solutions Oversees global product registrations and evaluates new products for regulatory impact, ensuring compliance with international regulations Leads and mentors a high-performing regulatory team, fostering collaboration and professional growth Required qualifications Bachelor's degree in a scientific or technical discipline required; professional medical device certification preferred 10+ years of experience in medical device regulatory affairs, including significant experience with Software as a Medical Device (SaMD) At least 5 years of leadership or management experience in a medium to large-sized organization Proven experience interacting with global regulatory authorities and managing regulatory submissions In-depth understanding of global medical device regulatory frameworks and cybersecurity expectations for connected software medical devices