Related skills
regulatory submissions fda 510(k) samd de novo regulatory compliance📋 Description
- Define and execute regulatory strategies for AI/ML SaMD globally.
- Prepare and manage submissions (FDA 510(k), De Novo, CE Mark, Health Canada).
- Lead regulatory coordination on projects with cross-functional teams.
- Ensure regulatory requirements are integrated into product development plans.
- Monitor AI/ML and SaMD regs; advise stakeholders.
- Support post-market regulatory activities and reporting.
🎯 Requirements
- Education: B.S. or higher in Life Science, Engineering or related.
- RAC preferred.
- 7+ years of medical device regulatory experience.
- 3+ years in AI/ML SaMD or software regulatory work.
- Experience in global regulatory submissions for medical devices.
- Excellent organizational, writing and verbal skills.
🎁 Benefits
- Remote-friendly with access to Denver, NY, Dallas and Lisbon offices.
- Travel for meetings monthly/quarterly; some roles may require up to 90% travel.
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