Head of Post Market Surveillance & Risk Management
In this role, you have the opportunity to
Be part of a fast-growing business that help improve the lives of millions of people, while advancing Philips digital transformation journey as a global leader in Health Technology. In this role, you will lead the Post Market Surveillance & Risk Management functions for the Precision Diagnostic cluster.
You are responsible for
- Leading the transformational strategy in Post Market Surveillance & Risk Management to assure timely & accurate product performance information is available to enable measurable decisions that drive product designs and improvement that delight our customers
- Leading the teams responsible for leading activities related to product safety surveillance and risk management including review of data from clinical studies and spontaneous complaints for accuracy, completeness, regulatory reporting and potential safety issues.
- Serving as key partner and liaison between Medical Affairs, Clinical Affairs, Research & Development, and Complaint Handling among others to ensure accurate product performance information is available to enable meaningful decisions that drive product designs and improvements that delight our customers
- Ensuring a proficient and capable organization with standardized and coordinated End to End Post Market Surveillance (PMS) and Risk Management (RM) processes
- Ensuring all relevant processes are complaint to all applicable regulations
- Ensuring standard Post Market Surveillance (PMS) and Risk Management (RM) processes across business units
- Assuring consistent PMS and RM documentation such as PMS plans and RM plans exists for all products
- Assuring, in collaboration with Medical Affairs and other critical partners, all product performance signals are assessed, and recommended actions implemented
- Assuring standard PMS and RM governance exists across Business Units
To succeed in this role, you should have the following skills and experience
- US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
- Bachelor’s degree in health science or similar healthcare-related field, such as Medical Doctor MD, Nursing, Radiology, Registered Pharmacist (RPH) , or equivalent (4 year degree required; additional education is desirable)
- 8+ years of proven ability in the pharmaceutical / medical device industry or direct device clinical experience
- Must have direct experience/knowledge of most regulations relative to PMS and RM activities such as: ISO 13485/14971, FDA Regulations (21CFR (803, 806, 82, etc.)), CMDR, JPAL, Medical Devices Directive (93/42/eec, 98/79/EC)), and EU MDR
- Demonstrates collaborative patient and customer focus
- Regulatory Affairs, Quality Assurance, or Complaint Handling experience in pharmaceuticals or medical devices
- Experience interacting with the FDA, ISO, and Other Regulatory Authorities
- English proficiency oral and written must have adequate computer skills to evaluate trending data, complete regulatory reports, and provide written correspondence to internal and external customers including regulatory bodies as appropriate.
- Excellent communications and analytical skills
- Leadership and supervisory skills
- In-depth knowledge of medical terminology
- Understanding of statistical fundamentals is preferred
- Experience with health hazard evaluations is preferred
In return, we offer you
A path towards your most exciting career. Philips is growing its marketing capability enterprise wide. Succeeding in this market-based role in a matrixed environment will open many doors for your long-term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities.
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.
It 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.
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