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Philips Head of Post Market Surveillance, Complaints Management in United States of America - Home Based, Massachusetts

null In this role, you have the opportunity to

Be part of a fast-growing business that helps 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 Complaints Management functions for the Precision Diagnostic cluster.

You are responsible for

  • Leading the transformational strategy in Complaints Management for the PD Cluster

  • Leading the Complaints Handling, Vigilance Reporting, and Post Market Surveillance organization to ensure customer complaints are timely evaluated and to assure reportable events are submitted timely according to worldwide regulations

  • Working with the Business leads to ensure resources required are in place to achieve objectives

  • Keeping up to date on changes in regulations and standards, and ensure that the Vigilance Reporting team is trained on applicable regulations and standards and any other training required to execute complaint investigations

  • Serving as key partner and liaison between Medical Affairs, Clinical Affairs, Research & Development, and Manufacturing among others to ensure complaints are process in a timely manner and to ensure complaints are looped back to the product lifecycle

  • Reviews MDRs/MIR reports ensuring that the information is accurate and complete as per applicable requirements

  • Supporting inquiries from Regulators and Notify Bodies related to complaints management activities

  • Supports and participates in audits

  • Ensures that procedures and processes are compliant to applicable regulations

  • Monitors and drive process improvements based on performance against metrics

You are a part of

A fast growing and innovative team, within an ever-changing environment - constantly striving for improvements and exceeding stakeholder expectations.

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.

  • Bachelors or Master of Science degree required.

  • Minimum ten (10) years in a quality systems or regulatory affairs role within a medical device, pharmaceutical, and/or medical diagnostics company

  • Minimum seven (7) years’ experience managing people

  • Experience with complaint handling in the medical device industry

  • Process improvement capabilities and experience

  • Good written and oral communications skills in English and proven track record to effectively communicate technical content to a range of internal and external audiences (e.g. Authorities, customers)

  • Ability to optimally balance and prioritize multiple ongoing projects/task

  • In-depth knowledge of Quality management systems. Proven work experience and knowledge with medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), EU Medical Device Regulation, Canadian Medical Devices Regulation (SOR/98-282), and Japanese MHLW Ordinance 169.

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.

Equal Employment and Opportunity Employer/Disabled/Veteran