ME, NH, MA, RI, CT, NY, NJ, DE, MD, VA, NC, SC, GA, FL, Netherlands – Telecommute
Medical Affairs Director
United States of America – Home Based
Netherlands – Home Based
In this role, you have the opportunity to
The position is the Medical Affairs Director for the Diagnostic Imaging Business, reporting directly to the Head of Clinical & Medical Affairs, Diagnostic Imaging. The role is responsible for providing medical leadership across all aspects of clinical safety, throughout product development and life-cycle management. This role acts across multi-functional teams as a valued individual contributor in providing medical input into all clinical safety related activities, with in-depth expertise in processes for safety assessments & surveillance, complaint analysis, & benefit-risk assessments.
You are responsible for:
Lead assessment of medical safety risk across Business / Cluster portfolio to enable informed patient-centric decisions
Safeguarding patient safety through medical input of relevant processes including Risk Management, Health Hazard Evaluations, Risk-Benefit analyses, recalls, review of post-market surveillance data to evaluate trends, etc
Provide authoritative medical support to R&D, Clinical Affairs, Regulatory Affairs, Post-Market Surveillance, Quality, Risk Management, Product Safety teams, Legal and Communications.
Contribute to risk management plans and failure mode analysis during product development and safety signal detection and post-market surveillance post-launch.
Participate in clinical safety discussions with KOLs, regulatory agencies / notified bodies, including during regulatory inspections.
Medical input into review of applications for Medical and Scientific Information
You are a part of:
As a result of Philips renewed dedication to Quality, it has recently restructured its organization to ensure you and your department have clear collaboration with Philips Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world.
To succeed in this role, you should have the following skills and experience
Position can be home based in the US, but must be East Coast, or home based in The Netherlands
An MD, MBChB, MBBS, or equivalent with 10+ years of years’ medical experience
At least 5+ years’ experience in medical device / biotech industry in medical affairs roles
Strong background and deep medical expertise in assessment of clinical risk-benefit throughout product development and life-cycle management
Deep knowledge and understanding of all applicable standards / regulations requiring medical input, such as risk management, complaint management, reporting requirements, etc
Shown ability to be strong advocate for patient-centric decision-making
Anticipates changing priorities and demands and addresses them enthusiastically
Ability to provide independent, medical input to critically evaluate clinical risk, and make evidence-based risk benefit determinations
Lead medical input into critical business decisions regarding potential patient safety issues
Analysis & interpretation of signals & trends from multiple inputs including clinical data, literature, complaints, etc
Excellent verbal, written and interpersonal skills required for working successfully in a cross-functional team environment
Medical & Health , Doctor & Practitioner , Healthcare Consultant , Health Administration
ME, NH, MA, RI, CT, NY, NJ, DE, MD, VA, NC, SC, GA, FL, Netherlands