Regulatory Affairs Specialist
Synefi
Join our compliance team to ensure Synefi's AI solutions meet the highest standards of regulatory compliance. You'll shape how we approach FDA, GxP, and other regulatory frameworks in our product development.
Responsibilities
- Monitor and interpret regulatory requirements affecting AI in pharma and medical devices
- Develop and maintain compliance documentation and validation protocols
- Advise product and engineering teams on regulatory implications of AI features
- Support clients with regulatory strategy for AI deployment
- Prepare submissions, audit responses, and compliance reports
Requirements
- 3+ years in regulatory affairs within pharma, biotech, or medical devices
- Deep knowledge of FDA 21 CFR Part 11, EU Annex 11, GxP guidelines
- Experience with computer system validation (CSV) and GAMP frameworks
- Strong analytical and technical writing skills
- Bachelor's degree in life sciences, regulatory affairs, or related field
Nice to Have
- RAC certification or advanced degree
- Experience with AI/ML regulatory considerations (FDA AI/ML action plan)
- Familiarity with ISO 13485, ISO 14971, or IEC 62304
Vacancy posted 16 hours ago
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