Medical Safety Manager - Complaints Handling at Philips

Bothell, Washington, United States -

Full Time

Start Date

Immediate

Expiry Date

14 Mar, 26

Salary

231840.0

Posted On

14 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Assessments, Regulatory Compliance, Post-Market Surveillance, Risk Management, Communication, Continuous Improvement, Patient Safety, Governance Meetings, Issue Impact Assessments, Health Hazard Evaluations, Team Development, Medical Safety, Technical Collaboration, Problem Solving, CFR Familiarity, ISO Standards Familiarity

Industry

Hospitals and Health Care

Description

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 5+ years of relevant experience with a bachelor’s or 3+ with a master’s equivalent in areas such as Medical/Clinical Affairs or Medical Safety/Medical Affairs Risk Management in Meical Device industry. Prior hands-on bedside/clinical experience required. 1+ years of post-market experience required; direct medical safety experience strongly preferred. 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 position. You’re an excellent communicator with an ability to work well cross functionally, and in a complex global working environment. How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is an office-based role. 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. Learn more about our culture. Philips Transparency Details The pay range for this position in Murrysville, PA is $129,375 to $207,000. The pay range for this position in Plymouth, MN is $135,844 to $217,350. The pay range for this position in Cambridge, MA, San Diego, CA and Bothell, WA is $144,900 to $231,840. The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. 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 here. At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. Additional Information 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. Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to posted locations. #LI-PH1 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.

Responsibilities

The Medical Safety Manager is responsible for performing clinical assessments on complaints related to harm and facilitating escalations between Post Market Surveillance and Medical Safety. This role also drives continuous improvement initiatives in post-market surveillance activities.