Associate Director, Regulatory Affairs (Medical Devices)

Major accountabilities:

• Develop and communicate RA MD regulatory strategies for projects across the life cycle (Development and On-Market).
• Ensure 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 functions clear, concise guidance on current device regulatory requirements to support planning and decision making.
• Lead and implement global Regulatory Affairs Medical Device (RA MD) submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products.
• Identify the required documentation and content, compliance and timelines issues for global 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 RA MD documentation for HA submissions, applying agreed RA MD Global regulatory strategies, current regulatory standards and guidelines.
• Lead, prepare and communicate RA MD risk management assessments, contingency plans, and lessons learned on major submissions and escalate as appropriate.
• Facilitate/support device related interactions with Health Authorities globally.
• Contribute to knowledge sharing, e.g. provide coaching within RA CMC and other functional areas
• Contribute to the development of new guidance, policy, and processes.

Minimum requirements:

• Experience in Medical Device Regulatory Affairs.
• Significant experience in the combination product or medical device industry.
• Proven knowledge of regulatory submission and approval processes for medical devices and combination products.
• Ability to critically evaluate data across diverse scientific disciplines.
• Understanding of product development and lifecycle management.
• Demonstrated success in leading and prioritizing multiple projects in global, cross-functional teams.
• Strong independent working skills with the ability to manage timelines and workload effectively.
• Excellent planning, organizational, and interpersonal skills.
• Proficiency in computer and IT systems.

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.