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Job Information

Philips Regulatory Affairs Director in Bothell, Washington

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In this role, you have the opportunity to

Lead the entire category Quality Systems, Regulatory Affairs, Development Quality, and Supplier Quality function of Philips Oral Healthcare Bothell, WA.

You are responsible for

  • Representing all quality aspects including development, product quality, supplier quality, quality systems and regulatory affairs.

  • Quality leader signoff of development project consolidations including project charter approvals, business reviews and product launch approvals.

  • Implementation of improvements identified internally and by CL Quality Leadership Team.

  • Collaboration with other functions including Innovation & Development, Marketing, Operations, Finance and Legal to assure coordinated efforts result in desired schedules and timelines for execution of new and revised existing products delivered to the market.

  • Regulatory Affairs responsibility for OHC products including country licensing and site licenses/certifications for all OHC products (medical devices, OTC and prescription pharmaceuticals, and cosmetics)

  • Customer Complaint Team leadership meeting FDA and ISO13485 requirements

To succeed in this role, you should have the following skills and experience

  • Bachelor’s degree in a scientific discipline or equivalent. An MS is desirable in technology, regulatory affairs, and/or MBA

  • Minimum 15-20 years experience in the medical device industry, pharmaceuticals, cosmetics and Class 1 and Class 2 devices

  • Minimum 10 years management experience, with strategic management experience preferred

  • Must be able to articulate and communicate effectively with employees at all levels of the Organization, as well as with key individuals outside the organization, which may include FDA staff, European government agencies, and other country governmental agencies.

  • Excellent presentation skills – verbal and PowerPoint

  • Multi-company and functional experience required, including Philips

In return, we offer you

A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this global role in a complex 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 strong health benefits, a flexible work schedule and access to local well-being focused activities. Furthermore, Philips University is available to all employees for learning and development opportunities.

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 age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.

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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