Senior Director, Regulatory Affairs (Medical Devices)

Healthcare Businesswomen’s Association; City Of London; Hybrid; GBP 65,000 - 85,000; Full time

Job summary

A healthcare organization in London seeks a seasoned regulatory expert to lead global strategy for digital medical devices, ensuring compliance and patient safety. The role requires a strong scientific background and extensive experience in regulatory affairs focusing on digital device submissions and approvals. Ideal candidates will have excellent communication skills and the ability to manage cross-functional projects.

Qualifications

• Significant experience in the digital device industry or regulatory agency.
• Knowledge in digital device regulatory submission and approval processes.
• Experience of leading regulatory health authority interactions.

Responsibilities

• Develop and communicate digital medical device regulatory strategies.
• Ensure regulatory risks are communicated to stakeholders.
• Lead global digital device submission activities.

Skills

Clinical Trials

Cross-Functional Teams

Regulatory Compliance

Risk Management

Strategy Execution

Education

Science Degree (e.g. Engineering, Chemistry, Pharmacy)

Job description

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 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 elevate 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