Director, Regulatory Affairs (Digital Medical Devices)
Posted 1 day 13 hours ago by Healthcare Businesswomens Association
Office Location: London (The Westworks), United Kingdom
(12 days per month on-site if living within 50 miles to our London office)
(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.
- 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.
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