Director, Regulatory Affairs (Digital Medical Devices)

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.