Medical Safety Director Imaging

Job Title

Medical Safety Director Imaging

Job Description

Medical Safety Director, Imaging

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 clinical safety related activities, with in-depth expertise in processes for safety assessments & surveillance, complaint analysis & benefit-risk assessments.

Your role:

• Lead medical safety across various Imaging businesses to enable informed patient-centric decisions.
• Safeguard patient safety through relevant processes including Risk Management, Health Hazard Evaluations (HHE’s), 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 Key Opinion Leaders (KOLs), regulatory agencies/notified bodies, including during regulatory inspections.
• Provide input into review of applications for Medical and Scientific Information.

You're the right fit if:

• You’ve acquired 3+ years of experience in medical safety within the medical device/biotech industry in medical affairs roles. Demonstrated experience leading medical input into critical business decisions regarding potential patient safety issues and analysis & interpretation of signals & trends from multiple inputs including clinical data, literature, complaints, etc. You have a demonstrated ability to anticipate changing priorities and demands and address them proactively.
• Your skills include 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.
• You have an MD or DO degree (required) with relevant experience to imaging medical devices (strongly preferred).
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Clinical position.
• You’re a strong advocate with a proven ability for patient-centric decision making, able to provide independent medical input to critically evaluate clinical risk and make evidence-based risk benefit determinations. You are willing and able to travel up to 25%, as required by business needs.

How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

This is a field role.

About Philips

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 business.
• Discover our rich and exciting history.
• Learn more about our purpose.
• Learn more about our commitment to diversity and inclusion.

Philips Transparency Details

The pay range for this position is $146,300-$295,680.

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.