Senior Director, Regulatory Affairs

2 weeks ago

London, Greater London, United Kingdom Novartis Full time £60,000 - £120,000 per year

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

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