Job Title
Medical Safety Manager Complaints Handling
Job Description
Medical Safety Manager, Complaints Handling
The Medical Safety Manager, Complaints Handling, performs clinical assessments on complaints related to harm to assist in regulatory reportability determination and serves as the primary clinical liaison between Post Market Surveillance and Medical Safety, facilitating escalations as necessary. This role makes harm severity and IMDRF coding determinations and drives continuous improvement initiatives in post market surveillance activities, collaborating with technical experts to resolve issues and support corrective actions.
Your role:
Accountable for preliminary clinical assessments for issues alleging injury or death for Philips products as well as providing input for Issue Impact Assessments/HHED.
Performs clinical assessments for Philips products involving injury or death allegations, contribute to Issue Impact Assessments/HHED, and ensure prompt escalation and resolution of complex complaints.
Participate in governance meetings, provide clinical insights for consistent decision-making, and serve as a subject matter expert in post-market surveillance activities to ensure regulatory compliance and patient safety.
Continuously evaluate and improve post-market surveillance processes, collaborate with global complaint handling and correction teams, and drive solutions to address gaps and enhance efficiency.
Communicate post-market clinical insights across businesses, markets, functions, and suppliers to support continuous improvement in complaint handling and corrections and removals for Philips products.
Support compliance with global regulations and internal quality standards, implement and refine operational processes for clinical input, and contribute to recruiting, developing, and coaching talent within the team.
You’re the right fit if:
You’ve acquired 10+ years of experience in Medical Safety/Medical Affairs Risk Management in the Medical Device industry. Prior hands-on bedside/clinical experience required. 4+ years of post-market experience required.
Your skills include familiarity with CFR, EUMDR, ISO standards, etc. Experience with Issue Impact Assessments, Health Hazard Evaluations, and Risk Benefit Analyses is preferred but not required.
You have a bachelor’s/master’s degree in medical science, Nursing, Respiratory Therapy or equivalent. Certified Professional in Patient Safety (CPPS) preferred.
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this ” target=”_blank” rel=”noopener noreferrer”>our business.
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In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found
This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.
Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.