Senior Manager, Regulatory Affairs

Job Summary

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