Director, Regulatory Affairs (Digital Medical Devices)

Novartis•Knoxville, TN

3d•Hybrid

About The Position

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.

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.

Nice To Haves

Clinical Trials
Cross-Functional Teams
Drug Development
Lifesciences
Negotiation Skills
People Management
Problem Solving Skills
Regulatory Compliance
Risk Management
Strategy Execution

Responsibilities

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.