Regulatory Affairs Specialist

Synefi; Boston, Northern (MA, KY); Hybrid; USD 120,000 - 170,000; Full time

Job summary

Synefi is seeking a Regulatory Affairs professional to join our compliance team in Boston. You will help ensure our AI-enabled pharma and medical device solutions meet FDA, EU, and GxP requirements throughout product development.

You will monitor regulatory changes, develop validation protocols and documentation, advise engineering teams on regulatory implications, support clients with regulatory strategy for AI deployment, and prepare submissions, audit responses, and compliance reports.

Qualifications

• 3+ years in regulatory affairs within pharma, biotech, or medical devices.
• 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.

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.

Skills

Regulatory affairs

FDA 21 CFR Part 11

GxP

CSV

GAMP

Analytical skills

Technical writing

Education

Bachelor's degree in life sciences or regulatory affairs

Job description

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