Medical Safety Manager, Enterprise Informatics

Job Title

Medical Safety Manager, Enterprise Informatics

Job Description

Medical Safety Manager (U.S. Home based)

The Medical Safety Manager for our Enterprise Informatics business is accountable for patient-centric end to end medical safety inputs and oversight for pre, and post approval products and Philips supported clinical studies and risk assessments.

Your role:

• Responsible for end-to-end clinical safety within the Enterprise Informatics (EI) business. You will ensure that clinical safety assessments are key inputs into the product development, quality, and regulatory processes. As the safety lead, you will help Philips provide customers with products and solutions that not only meet regulatory safety standards, but also deliver best-in-class patient care. A medically independent voice is key; however, collaboration in ensuring clinical safety is expected.
• Providing objective medical safety and clinical input for the valuation of potential safety issues for products in the field (IIA/HHE). Represent Medical Affairs Safety in Correction and Removal Board meetings.
• Providing objective medical safety and clinical input to product Safety Risk Assessment (SRA) or Risk Management Matrix (RMM) documents including severity, probability, and use case scenarios.
• Providing Medical Safety review and input into post-market deliverables such as Post-Market Surveillance Reports, Periodic Safety Update Reports, and Post-Market Clinical Follow-Up Reports.
• Proactively collaborate with cross-functional teams to provide medical safety and clinical input for end-to-end product lifecycle development, including change request disposition, verification and validation, customer inquiries, regulatory and clinical compliance assessments, and competitor assessments.

You're the right fit if:

• You’ve acquired 3+ years of clinical experience in a hospital environment preferred; 2+ years of experience in clinical safety roles within the medical device industry required. Experience with literature searches and evidence-based practice. Software or SaMD experience is a plus but not required. Risk Assessment experience is a plus as well.
• Your skills include high-level writing skills and acute attention to detail. Excellent interpersonal and problem-solving skills; passion for clinical safety, quality, and innovation. Strong understanding of post-market surveillance regulations (21 CFR, MDD93/42/EEC and other applicable global regulations, ISO 14971 (Risk Management)).
• You have an appropriate clinical training background such as MD, DDS, DO, PA, RN, APRN, medical informatics, etc. and an active clinical license (preferred).
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.
• The ideal candidate will be in or around Cambridge, MA area however we will consider qualified candidates located near other posted hub locations.

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.
• Read more about our employee benefits.

If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.

Philips Transparency Details

The pay range for this position is $116,200 to $223,104, annually.  The actual base pay offered may vary depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.   

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