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Philips CC Regulatory Program Manager in United States of America - Home Based, Massachusetts

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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 c ontact 888-367-7223, option 5, for assistance.

In this role, you have the opportunity to

Responsible for developing and implementing global regulatory strategy and roadmaps through deep understanding of the competitive market landscape, regulatory / legislative initiatives, and product marketing strategy.

You are responsible for

  • Responsible for product registrations/approvals.

  • Leads regulatory resources to ensure timely product registrations, regulatory planning for new product introductions and product changes, and in maintaining regulatory compliance.

  • Advises product design teams on regulatory strategy and requirements for specific new products/solutions.

  • Provides the regulatory plan, guidance on risk assessment, and required corrective actions to meet regulatory requirements, as well as leadership and guidance on global regulatory strategy, such as CE Marking, product registrations, and clinical evaluations.

  • Has wide-ranging experience, using professional concepts and company objectives to resolve complex issues in creative and effective ways.

  • Some barriers to entry exist at this level (e.g., dept./peer review). Level at which career may plateau.

  • Distinguished by additional specialized knowledge in breadth and/or depth, as well as record of success in relevant business process/function.

  • Viewed as an expert in the field.

  • May have a leadership role.

  • Has expert level knowledge of company products and services and may be tasked with introducing new concepts.

  • Regularly interacts with senior management or executive levels on matters concerning several functional areas, divisions, and/or customers.

  • Works on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives.

  • Implements strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results.

  • Establishes and assures adherence to budgets, schedules, work plans, and performance requirements.

  • This position is responsible for managing a part of a business process or function.

You are a part of

Philips is one of the world's leading healthcare technology companies. We are committed to understanding the technological and human needs of patients and caregivers and to delivering solutions that enable more confident diagnoses, more efficient delivery of care, and more positive user experiences. People focused. Healthcare simplified.

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. 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 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.

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

Required:

  • Bachelor’s degree in a technical discipline, RAPS certified preferred.

  • Minimum of 6 years of experience in the medical device industry and technical environment with at least 5 years in an medical device company (FDA Class II equivalent – Class III a plus).

  • Must have experience with successful preparation and submission of 510(k), PMA, or international documents or registration and marketing of medical device worldwide

  • Strong background in Design Controls.

  • Excellent working knowledge of medical device regulations (21CFR), FDA law, EU MDR, other global laws and regulations.

  • Experience in supporting international registrations and clinical investigations.

  • Approx. 20% travel annually with some international.

Ready to start improving lives by putting your personal skills & passions to work? Apply Today! Not yet ready to apply? That’s okay! Learn more about us by joining our Talent Network on LinkedIn or following us on Twitter at @PhilipsJobsNA.

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

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