Medical Safety Manager – Complaints Handling
Philips
full-time
Posted on:
Location Type: Remote
Location: California • Massachusetts • United States
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Salary
💰 $122,906 - $231,840 per year
About the role
- perform clinical assessments on complaints related to harm
- assist in regulatory reportability determination and serve as the primary clinical liaison between Post Market Surveillance and Medical Safety
- make harm severity and IMDRF coding determinations
- drive continuous improvement initiatives in post market surveillance activities
- collaborate with technical experts to resolve issues and support corrective actions
- provide clinical insights for consistent decision-making in governance meetings
- ensure regulatory compliance and patient safety
- evaluate and improve post-market surveillance processes
- support compliance with global regulations and internal quality standards
Requirements
- 5+ years of relevant experience
- bachelor's or 3+ years with master's equivalent in Medical/Clinical Affairs or Medical Safety/Medical Affairs Risk Management in Medical Device industry
- prior hands-on bedside/clinical experience
- 1+ years of post-market experience required; direct medical safety experience strongly preferred
- familiarity with CFR, EUMDR, ISO standards, etc.
- experience with Issue Impact Assessments, Health Hazard Evaluations, and Risk Benefit Analyses preferred but not required
- bachelor's/master’s degree in medical science, Nursing, Respiratory Therapy or equivalent
- Certified Professional in Patient Safety (CPPS) preferred
- must be able to successfully perform minimum Physical, Cognitive and Environmental job requirements with or without accommodation.
- excellent communication with the ability to work cross-functionally in a complex global working environment.
Benefits
- PTO
- 401k (up to 7% match)
- HSA (with company contribution)
- stock purchase plan
- education reimbursement
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical assessmentsregulatory reportability determinationharm severity determinationIMDRF codingpost-market surveillanceIssue Impact AssessmentsHealth Hazard EvaluationsRisk Benefit Analysesregulatory compliancepatient safety
Soft Skills
collaborationcommunicationdecision-makingcontinuous improvementcross-functional teamwork
Certifications
Certified Professional in Patient Safety (CPPS)