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 Qualifications 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 #J-18808-Ljbffr Jobtailor