Looking at the challenges the world is facing today Philips’ purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you’ll be working towards creating a better and fairer future for all.In this role you have the opportunity toWorks with a variety of diverse persons within the company such as Complaint Investigators, PMS Clinical Experts, CH Market Experts, Engineers, Scientists, Field Service & Application Engineers and Manufacturing personnel to facilitate reportable device events in accordance with written procedures and global reporting requirements.Your role:
Works with a variety of diverse persons within the company such as Complaint Investigators, PMS Clinical Experts, CH Market Experts, Engineers, Scientists, Field Service & Application Engineers and Manufacturing personnel to facilitate reportable device events in accordance with written procedures and global reporting requirements.
Utilizes global decision trees and country specific exemptions to determine worldwide complaint reporting requirements and serious public health threat applicability in accordance with written procedures and global reporting requirements
Collaborates with Level 3 complaint investigator to determine the need for Clinical Assessment and Clinical Harm Review.
Provides review of complaint to ensure all information needed for Reporting/MDRs is present; determine if further investigation is needed and track investigation to conclusion.
Writes MDRs/MIR reports and submits to the necessary authorities
Monitors and improves tracking/control systems for medical device reporting
Investigates and prepares responses to address Competent Authority inquiries and provide follow‐up
May perform complaint investigation activities upon request
May perform other duties as assigned
You're the right fit if:US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.Required:
Bachelor’s Degree or higher in biomedical engineering, science, healthcare, or medical profession (Associates degree may be considered for individuals with at least 1 years hands‐on patient care experience or experience with servicing or supporting the product(s) or similar product(s) in the field).
Excellent reading and writing skills.
Preferred:
Previous experience working as a biomedical engineer/risk manager OR in a licensed/certified capacity in a health care role such as an RN, NP, PA, MD, (Respiratory Therapist, Radiation Technologist, Ultrasound Technologist, CT technologist, EMT, etc. may be considered if applicable to product being supported) OR previous experience with servicing or supporting the product or similar products in the field OR previous experience working as a Vigilance Reporting Specialist supporting the product(s) or a similar product(s).
1 years’ experience Medical Device and or other regulated industry.
Basic understanding of CAPA, as well as global medical device regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO1497, and ISO9001.
Global post market surveillance regulation (21CFR, MDD93/42/EEC and other applicable global regulations), ISO14971 Risk Management.
About PhilipsWe 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.
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Discover our rich and exciting history.
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Read more about our employee benefits.
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.Philips Transparency DetailsThe pay range for this position is $56,000,000 to $90,000, Annually. The actual base pay offered may vary 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 InformationUS 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.#LI-PHIIt is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.Equal Employment and Opportunity Employer/Disabled/Veteran