Director, Regulatory Affairs

Choose LocationChoose Location# Director, Regulatory Affairs (Digital Medical Devices)REQ-10064222Nov 10, 2025United Kingdom### Summary#LI-Hybrid (12 days per month on-site) Location: London (The Westworks), United Kingdom We’re looking for a seasoned regulatory expert to lead global strategy and execution for digital medical devices, including Digital Health Technologies (DHTs) and Software as a Medical Device (SaMD).Maximise your chances of a successful application to this job by ensuring your CV and skills are a good match.This role drives regulatory direction across development, registration, and post-approval, ensuring timely, compliant decisions that balance patient safety and business needs.### About the Role**Major accountabilities:*** Develop and communicate digital medical device regulatory strategies for projects across the life cycle (Development and On-Market).* Ensure digital device regulatory risks and key issues are communicated in a timely manner to project teams and other stake holders.Represent de-partment in cross-functional project teams as appropriate.* Provide Novartis technical and clinical functions clear, concise guidance on current digital device regulatory requirements to support planning and decision making.* Lead and implement global digital device submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products* Lead the identification of the required documentation and content, compliance and timelines issues for global digital device submissions and work collaboratively with cross-functional teams for the delivery of technical source documents in accordance with project timelines.* Author and/or review compliant digital device documentation for HA submissions, applying agreed digital device global regulatory strategies, current regulatory standards and guidelines.* Lead, prepare and communicate digital device risk management assessments, contingency plans, and lessons learned on major submissions and escalate as appropriate.* Drive digital device related interactions with Health Authorities globally.* Knowledge sharing, e.g.provide coaching within Regulatory Affairs and other functional areas.* Development of new digital device regulatory guidance, policy, and processes.**Minimum requirements:*** Science Degree (e.g.Engineering, Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent.* Significant experience in the digital device industry or regulatory agency with responsibility for digital devices.* Significant knowledge/experience in digital device regulatory submission and approval processes.* Demonstrated practical experience in digital device regulatory affairs (e.g.IDE/510(k)/PMA filings; application of digital device quality management systems, software validation, human factors, design verification/validation requirements).* Experience of leading regulatory health authority interactions, inspections and/or external advocacy/regulatory policy.* Ability to critically evaluate data from a broad range of scientific disciplines.* Knowledge of digital device development and life cycle management.* Ability to work independently and successfully with global project teams and prioritize activities considering timelines and workload.**Commitment to Diversity & Inclusion**Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve. xpwpeyx **Why Novartis:****Join our Novartis Network:****Benefits and Rewards:** Read our handbook to learn about all the ways we’ll help you thrive personally and professionally:DevelopmentUniversal Hierarchy NodeUnited KingdomLondon (The Westworks)GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd.Research & DevelopmentFull timeRegularNoNovartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.REQ-10064222### Director, Regulatory Affairs (Digital Medical Devices)#J-18808-Ljbffr