Senior Manager, Regulatory Affairs
Job Summary
Leading global regulatory strategy for software and AI/ML-enabled products, the full-time Senior Manager, Regulatory Affairs will collaborate with cross-functional teams to navigate regulatory complexities and ensure compliance while working remotely.
Key responsibilities
- Own global regulatory strategy for software and AI/ML-enabled products, balancing risk and innovation
- Serve as a regulatory partner to Product, Engineering, Clinical, Quality, and Legal teams, providing actionable insights on high-priority initiatives
- Monitor global regulatory developments and advise on emerging requirements in AI/ML, digital health, and cybersecurity
Required qualifications
- 12+ years in Regulatory Affairs with expertise in digital health and AI/ML
- Experience engaging with the FDA and international regulatory authorities on complex software and AI/ML products
- Deep knowledge of global regulatory frameworks governing AI/ML, software lifecycle, and cybersecurity
- BSc or MSc in Biomedical Engineering, Computer Science, Data Science, Software Engineering, or a related field; advanced degrees valued
- Proven ability to influence stakeholders and translate regulatory concepts into practical business recommendations
Complete Job Description
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