Regulatory Affairs Specialist

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Job description

If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request. You may contact , option 5, for assistance.

The Regulatory Affairs Specialist is responsible for developing and implementing global regulatory strategy, roadmaps, and associated product labeling through deep understanding of the competitive market landscape, regulatory / legislative initiatives, and product marketing strategy.

You are responsible for:

• Assisting with implementation of global regulatory and roadmaps through understanding the Competitive market landscape and product Marketing strategy.
• Advising product design teams on regulatory strategy and requirements for specific new products/solution.
• Regulatory planning for new product introductions and product changes, and assist in maintaining regulatory compliance.
• Supporting the development of the regulatory plan, guidance on risk assessment, and required corrective actions to meet regulatory requirements, and product registrations such as CE Marking and clinical evaluations.
• Develops and facilitates regulatory submissions, for new products/solutions, existing products/solutions.
• Review and approve engineering changes and labeling for regulatory compliance.
• Identify potential regulatory approval risks based on changes in regulations, standards, country specific issues or other unique characteristics of the project.
• Creates, reviews and validates marketing and labeling materials while supporting projects and other key regulatory activities.

You are a part of:

Philips Oral Healthcare team in Bothell, WA. Our global Oral Healthcare team provides opportunities to develop your career in a variety of ways; work on global team projects, work with business leaders and influencers to drive change, improve health outcomes and deliver meaningful experiences for patients and families. We are a highly entrepreneurial organization, passionate about developing innovations that meet consumer's personal health & well-being needs in a unique way, relative to their Mind, Body, and Appearance. Our passion in Oral Healthcare will tap into your innovation with new experiences & desire to make a real impact on our customer's personal health.

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

• 5+ years of relevant professional experience within a regulated environment, Medical device preferred. Education: Bachelor's degree or equivalent.
• Must have experience with successful preparation and submission of 510(k), PMA, Technical Files, or international documents or registration, labelling and marketing of medical device worldwide
• Some experience in Design Controls
• Working knowledge of medical device regulations (21CFR), FDA law, MDD/MDR, other global laws and regulations.
• Experience in supporting international registrations and clinical investigations
• US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

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 competitive 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 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 , option 5, for assistance.

Equal Employment and Opportunity Employer/Disabled/Veteran

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