Medical Safety Manager Complaints Handling

Philips

4d•$133,000 - $237,000•Onsite

About The Position

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.

Requirements

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.
Familiarity with CFR, EUMDR, ISO standards, etc.
Bachelor’s/master’s degree in medical science, Nursing, Respiratory Therapy or equivalent.
Excellent communicator with an ability to work well cross functionally, and in a complex global working environment.
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
For this position, you must reside in or within commuting distance to posted locations.

Nice To Haves

Experience with Issue Impact Assessments, Health Hazard Evaluations, and Risk Benefit Analyses is preferred but not required.
Certified Professional in Patient Safety (CPPS) preferred.

Responsibilities

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.