Senior Director, Regulatory Affairs (Medical Devices)

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

 

Job Description

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.

 

Skills Desired

Clinical Trials, Cross-Functional Teams, Drug Development, Lifesciences, Negotiation Skills, People Management, Problem Solving Skills, Regulatory Compliance, Risk Management, Strategy Execution