Director, International Regulatory Affairs

📋 Description

• Define and oversee global regulatory strategies for the product portfolio.
• Lead regulatory strategy for commercialization across EU, APAC, ME, UK.
• Direct international regulatory submissions, registrations, and lifecycle activities.
• Establish filing strategies, submission plans, timelines, governance.
• Partner with exec leadership and cross-functional teams to embed regulatory considerations.
• Maintain readiness for inspections and regulatory negotiations across markets.

🎯 Requirements

• Advanced degree in molecular biology, genomics, diagnostics, or related field; PhD preferred.
• 15+ years of regulatory affairs experience; alternative thresholds with advanced degree.
• Proven success leading enterprise regulatory strategies and major submissions (international
• Experience engaging with senior leaders at global regulators; influence policy.
• Strong knowledge of IVDD/IVDR, FDA 21 CFR, UK MDR 2002; GMP/ISO 13485; ISO 14971.
• Familiarity with CAP, CLIA, NYSDOH, ISO 15189; HIPAA and GDPR privacy rules; ICH E6/GCP.

🎁 Benefits

• Base salary: $169,000–$242,000 annually in the United States.
• Potential for bonuses or incentive programs.
• Comprehensive medical, dental, and vision coverage.
• 401(k) with employer matching.
• Flexible time-off; mindfulness and well-being programs.