Global Regulatory Affairs Device Lead (Associate Director)

About This Role

This role drives global regulatory strategies for medical devices and combination products, collaborating with cross-functional teams to navigate complex regulatory landscapes and optimize product development. The lead will directly influence product approvals through strategic negotiations with health authorities worldwide.

Responsibilities

• Serve as GRA Device Lead on assigned project teams (early phase, late stage and marketed products)
• Provide regulatory guidance and advice to Global Regulatory Team (GRT) and cross-functional teams
• Develop and execute innovative and sustainable medical device regulatory strategies covering stand-alone medical devices and device part of combination products elements
• Define device Health Authority interactions plan, lead device related health authority interactions and support cross-functional health authority interactions
• Identify medical device regulatory acceleration opportunities and regulatory risks, and propose thoughtful risk mitigations in collaboration with the GRT
• Lead global filing and lifecycle management activities for device submissions/device aspects of medicinal product submissions
• Prepare, review and approve design control deliverables
• Contribute to product development and lifecycle management planning
• Provide regulatory impact assessments for proposed product changes
• Participate in the development and monitoring of the global regulatory environment and updating of standards and processes related to device regulations

Requirements

• 8+ years of relevant pharmaceutical/biotechnology/medical device industry experience
• 5+ years of medical device and/or combination product regulatory experience with contributions to regulatory filings and implementation of regulatory strategies
• Experience responding to Health Authority questions
• Experience preparing regulatory documentation and familiarity with standard submission processes
• Understanding of clinical development of medicinal products, device/IVD development (including design controls), manufacturing processes, and regulatory requirements in major markets
• Working knowledge with technical/industry standards related to medical devices
• Ability to synthesize and critically analyze data from multiple sources
• Bachelor's degree in a scientific or engineering discipline
• Fluency in English

Qualifications

• Bachelor's degree in a scientific or engineering discipline. Graduate degree preferred.
• 8+ years of relevant pharmaceutical/biotechnology/medical device industry experience with 5+ years of medical device and/or combination product regulatory experience with contributions to regulatory filings

Nice to Have

• Graduate degree

Benefits