Medical Director
2 weeks ago
Medical Safety Director
The Medical Safety Director is responsible for providing medical leadership across all aspects of medical 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 medical safety related activities, with in-depth expertise in processes for safety assessments & surveillance, complaint analysis & benefit-risk assessments.
Lead medical safety across various businesses to enable informed patient-centric decisions.Safeguard patient safety through 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, Legal & Communications.Contribute to risk management plans and failure mode analysis during product development, safety signal detection and post-market surveillance post-launch.
Participate in clinical safety discussions with KOLs, regulatory agencies / notified bodies, including during regulatory inspections.Provide input into review of applications for Medical and Scientific Information.
MD, MBChB, MBBS, DO or equivalent with 3+ years direct medical safety experience in medical device/biotech industry
A strong background and deep medical expertise in assessment of clinical risk-benefit throughout product development life-cycle.
Deep knowledge and understanding of all applicable standards / regulations requiring medical input, such as risk management, complaint management, reporting requirements, etc.
Ability to provide independent, medical input to critically evaluate clinical risk, and make evidence-based risk benefit determinations.Leading 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.
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
We are a health technology company.We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve.
Do the work of your life to help improve the lives of others.Learn more about our commitment to diversity and inclusion here.
The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
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