Director, Regulatory Affairs (Digital Medical Devices)

Job Description Summary

Office Location : London (The Westworks), United Kingdom

#LI-Hybrid (12 days per month on-site if living within 50 miles to our London office)

#LI-Remote (if living beyond 50 miles to our London office)

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). This role drives regulatory direction across development, registration, and post-approval, ensuring timely, compliant decisions that balance patient safety and business needs.

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 stakeholders. Represent department 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 escape 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

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.

Skills Desired

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