Senior Regulatory Manager, Medical Devices & Combos

• 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

• Identifies medical devices regulatory acceleration opportunities and regulatory risks, and proposes thoughtful risk mitigations in collaboration with the GRT

• Identify issues and opportunities that impact submissions timelines; ensures appropriate communication, resolution and/or escalation as needed

• Support global filing and lifecycle management activities for device submissions/device aspects of medicinal product submissions

• Liaises 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

• Supports operational and compliance activities for assigned deliverables, develops, executes regulatory submission planning activities, including generating submission content plans, submission tracking, communication and document management.

Requirements

• 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.

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Hard Skills

• Regulatory Filing
• Design Control
• Change Control
• Regulatory Impact Assessment
• Submission Tracking

Soft Skills

• Strong Communication Skills
• Cross-Functional Collaboration
• Problem-Solving