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In this role, you have the opportunity to

The position requires a person with energy, commitment to excellence, and ability to work in a fast-paced, technically skilled, team setting environment with minimal supervision. Responsible for developing strategies for worldwide regulatory approval, preparing US and EU submissions, and ensuring timely and high-quality execution of all regulatory deliverables. Keeps abreast of regulatory procedures and changes. Provides support for global regulatory approvals, and ensures compliance with Philips and government requirements.

You are responsible for

• Serve as RA Representative on project teams, develops regulatory submission strategies for new product launch, and provide regulatory guidance to the project teams.

• Responsible for coordinating the planning, preparation, assembly, review and publication of regulatory submissions to the FDA, EU and other worldwide government agencies. Ensure regulatory submissions are accurate and verifiable against source documents to confirm compliance and traceability.

• Maintain regulatory documentations to support compliance with regulatory requirements.

• Participants in internal and external Quality System Audits.

• Fulfills selected Quality System requirements as described within the Quality Systems (related to regulatory assessments, promotional materials review, change order reviews, CAPA reviews).

• Fulfills selected requirements under the European MDR, MDD, Japan PAL and Canada CMDR, etc. as defined within SOPs and other documents.

• Evaluate compliance related issues (GMP, GCP, GLP) and participate in the development of action plans to correct deficiencies.

• Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations.

You are a part of

The Philips Ultrasound Team. Our mission is to improve the lives of 3 billion people per year by 2030. Every day we move closer to achieving our goal by creating cutting-edge solutions that lead to confident diagnosis, improved care, and increased quality of life for patients. Our QMS is an enabler for this mission.

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

• Bachelor degree in Life Sciences or related field, with 2+ years of experience in medical device regulatory or quality assurance field.

• Master or higher degree in Life Sciences or related field, with 1+ years of experience in medical device regulatory or quality assurance field

• Must possess knowledge of Quality System requirements and FDA and/or International product approval process.

• Experience with software development or regulatory submission as a plus.

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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