Medical Safety Manager

2 months ago

Orlando, Florida, United States Philips Full time

Medical Safety Manager- Sleep & Respiratory Care (Pittsburgh preferred or US hub based, hybrid)

The Medical Safety Manager for our Sleep & Respiratory Care business will be primarily involved in issue impact assessments (IIA), health hazard evaluations (HHE), and updating and improving existing medical documentation. 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.

Your role:

  • Responsible for end-to-end clinical safety within the Sleep & Respiratory Care business. You will ensure that medical safety assessments are key inputs into the product development, quality, and regulatory processes.
  • Providing objective medical safety and clinical input for the evaluation 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, Period 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 and/or home care environment including ventilators/CPAP devices, and care of patients who require mechanical ventilation (invasive ventilation, non-invasive ventilation, high-flow oxygen therapy). You must be a licensed healthcare provider with a current active license. 2+ years' experience in medical safety roles within medical device industry strongly preferred.
  • Your skills include experience with literature searches and evidence-based practice, high level writing skills and acute attention to detail. You have excellent interpersonal and problem-solving skills; passion for medical safety, quality, and innovation. You have a strong understanding of post market surveillance regulations (21 CFR, MDD93/42/EEC and other applicable global regulations), and ISO
  • You are a Registered Respiratory Therapist (RRT) required; with advanced respiratory credentials preferred (eg. NPS, CPFT, ACCS).
  • You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote ,-cognitive-and-environmental-pce-job-requirements) position.
  • Minimal travel required (

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