Senior Manager, GRA Device Associate – Medical Devices and Combination Products

Responsibilities

• Partner with the Device Regulatory Lead on assigned projects
• Provide regulatory guidance and advice to Global Regulatory Team (GRT) and cross-functional teams
• Contribute to and execute innovative and sustainable medical device regulatory strategies covering stand‑alone medical devices and device part of combination products elements
• Contribute to device Health Authority interactions plan, support device related and cross‑functional health authority interactions
• Identify medical devices regulatory acceleration opportunities and regulatory risks, and propose thoughtful risk mitigations in collaboration with the GRT
• Identify issues and opportunities that impact submission timelines; ensure appropriate communication, resolution and/or escalation as needed
• Support global filing and lifecycle management activities for device submissions / device aspects of medicinal product submissions
• Liaise with device, clinical, manufacturing, commercial, and other internal business partners to enable successful regulatory outcomes
• Prepare and review design control deliverables
• Contribute to product development and lifecycle management planning
• Provide regulatory impact assessments for proposed product changes
• Support operational and compliance activities for assigned deliverables, develop, execute regulatory submission planning activities, including generating submission content plans, submission tracking, communication and document management

• Bachelor's degree in a scientific or engineering discipline
• Advanced degree (Master or PhD) preferred
• 6+ years of relevant pharmaceutical or biotechnology or medical device industry experience
• 3+ years of regulatory experience (combination of CMC, device, and combination product) with contributions to regulatory filings and implementation of regulatory strategies
• Experience responding to Health Authority questions
• Familiarity with implementing device regulatory strategies to support product development, clinical use, and commercialization, including change controls
• Familiarity with preparing regulatory documentation and standard submission processes
• Understanding of drug clinical development, device development (including design controls), and working knowledge with technical/industry standards related to medical devices
• Ability to work effectively in a matrix environment, engaging cross‑functionally with R&D, Device, Manufacturing, and Quality teams
• Strong written and verbal communication skills, with fluency in English