synefiBrooklyn, NY
Regulatory Affairs Specialist
Regulatory Affairs Specialist
Regulatory Affairs Specialist
synefiBrooklyn, NY
today
Electromedical and Electrotherapeutic Apparatus ManufacturingSurgical and Medical Instrument ManufacturingPharmaceutical Preparation Manufacturing
Apply for this role →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 HaveRAC certification or advanced degree
Experience with AI/ML regulatory considerations (FDA AI/ML action plan)
Familiarity with ISO 13485, ISO 14971, or IEC 62304
Also on the board Same function, level within a rung
Level
Lead
Location
Brooklyn, NY
Occupation
Regulatory Affairs Specialists
Industry
Electromedical and Electrotherapeutic Apparatus Manufacturing
Posted
today