Philips Director, Q&R Post Market Surveillance in Highland Heights, Ohio

  • Key area of responsibility• Manages teams responsible to prepare records for and support regulatory inspections, specifically in Post Market Surveillance• Manages a high-volume of complaints, MDRs, and Recalls• Leading projects and collaborating with program leadership and other individual contributors associated with work streams to ensure alignment of day-to-day operations• Performs project planning, change management, communication planning, and data verification to ensure compliance to regulatory requirements• Serves as a change leader within the business, contributing to key change initiatives• Formulates and recommends changes to policies and establishes procedures that affect regulatory compliance.• Manages compliance to FDA regulations and other Regulatory Agencies as required, guidelines and policies to all products and operations are consistent with those regulations.Minimum Qualifications:• Master’s or PhD degree or equivalent experience10+ years of relevant experience in a medically regulated and technical environment in (FDA Class I or II equivalent – Class III a plus).Desired Qualifications:• MBA• Experience in a medically regulated and technical environment in (FDA Class I or II equivalent – Class III a plus)).Skills:• Demonstrated experience developing and creating strong functional teams with robust talent pipeline.• Strategic Thinker• Quality Oriented• Business Acumen• Effective Communicator• Relation builder/ networker

In this role, you have the opportunity to

The Director of Post Market Surveillance is responsible to manage and develop the Post Market Surveillance team to achieve all business objectives. Reporting to the Head of Quality & Regulatory (Q&R) of Computed Tomography / Advanced Molecular Imaging (CT/AMI) he/she works with the Business leads to ensure Post Market Surveillance resources required are in place to achieve objectives. Hereby he/she works with Idea to Market (I2M) and Order to Cash (02C) to ensure the effectiveness and efficiency of complaint investigation processes including data output to support improvement of I2M and 02C processes as well as the Corrections and Removal process. Develop, deploy and manage the Post Market Surveillance quality system element components to ensure effectiveness, efficiency and compliance.

You are responsible for

  • Manages teams responsible to prepare records for and support regulatory inspections, specifically in Post Market Surveillance

  • Manages a high-volume of complaints, MDRs, and Recalls

  • Leading projects and collaborating with program leadership and other individual contributors associated with work streams to ensure alignment of day-to-day operations

  • Performs project planning, change management, communication planning, and data verification to ensure compliance to regulatory requirements

  • Serves as a change leader within the business, contributing to key change initiatives

  • Formulates and recommends changes to policies and establishes procedures that affect regulatory compliance.

  • Manages compliance to FDA regulations and other Regulatory Agencies as required, guidelines and policies to all products and operations are consistent with those regulations. To succeed in this role, you should have the following skills and experience Minimum Qualifications:

  • Master’s or PhD degree or equivalent experience

  • 10+ years of relevant experience in a medically regulated and technical environment in (FDA Class I or II equivalent – Class III a plus).Desired Qualifications:

  • MBA

  • Experience in a medically regulated and technical environment in (FDA Class I or II equivalent – Class III a plus)).Skills:

  • Demonstrated experience developing and creating strong functional teams with robust talent pipeline.

  • Strategic Thinker

  • Quality Oriented

  • Business Acumen

  • Effective Communicator

  • Relation builder/ networker

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 at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video .

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech/philips-recruitment-process.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .

Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.

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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