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Senior Regulatory Affairs Expert
HybridFull-timeMedical Devices
Lead regulatory affairs for radiology imaging software and AI-enabled medical devices, guiding market access, compliance, risk decisions, submissions, and team capability development.
Responsibilities
- Represent regulatory affairs on the radiology informatics leadership team
- Develop and execute end-to-end regulatory strategies throughout the product lifecycle
- Manage the day-to-day operations of the radiology regulatory team
- Assess regulatory risks for portfolio selection and post-market decisions
- Build strategic relationships with Notified Bodies, the FDA, Competent Authorities, and other external stakeholders
- Partner with R&D, Product Management, Quality, Clinical Affairs, and local regulatory teams
- Mentor regulatory professionals and develop team capabilities
Requirements
- Bachelor’s degree or equivalent, preferably in informatics, engineering, or life sciences
- At least 10 years of regulatory affairs experience in the medical device industry
- Experience with software-enabled medical devices, Software as a Medical Device, AI, digital health, cloud computing, and associated development methodologies
- Extensive experience authoring FDA and other regulatory submissions, including pre-submissions, IDEs, 510(k)s, and Technical Files or Design Dossiers
- Knowledge of global regulatory policies, FDA and EU MDR guidance, quality management systems, safety risk management, software development lifecycles, cybersecurity, and labeling
- Ability to collaborate with cross-functional teams and leadership
Nice to have
- Experience with radiology software devices and mature installed bases
- Experience with AI/ML-enabled device authorizations in radiology settings