Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.

But it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique individuals, with two things in common: An unwavering sense of purpose and a relentless determination to deliver on our customers’ needs. It’s what inspires us to create meaningful solutions – the kind that make a real difference – when it matters most.

The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.

In this role, you have the opportunity to make life better

Looking at the challenges the world is facing today Philips’ purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you’ll be working towards creating a better and fairer future for all.

In this role, you have the opportunity to

Ensure that products comply with all the relevant safety and environmental policies and regulations by implementing requirements, conditions, and enablers for SaMD products supporting the Cardiologs business within Ambulatory Monitoring and Diagnostics (AM&D). The Sr. Regulatory Affairs Specialist is responsible for preparing comprehensive regulatory strategies for complex software devices and significant post-market changes and international expansion into new markets.

You are responsible for

• Management of Regulatory submission deliverables

• Point of contact for Regulatory activities with internal and external stakeholders

• Participate actively in QMS improvement. Seek and drive continuous improvement initiatives

• Review and interpret regulatory guidelines and keep up to date with US, EU and global market regulations and communication in an organized manner

• Support internal and external audits (CE, FDA, MDSAP, global audits)

• Gather requirements and documentation and help build regulatory guidance and strategy in US and global regions

• Collaborate with the Commercial team to ensure support is provided and products remain in compliance with applicable regulations and internal procedures

• Provide regular trainings to the team

• Manage Product change control process: Ensure product compliance: guarantee that regulatory requirements are met in regard to local and international regulations and company standards. Maintain & update of technical files and necessary documentation for product release. Responsible for release of the product.

You are a part of

The Cardiologs team, which is part of the Ambulatory Monitoring & Diagnostics Group (AM&D), reflecting its powerful position in patient care management in ambulatory and home care settings. Building on its strength in ambulatory electrocardiography, diagnostics, and mobile monitoring, you will be part of the team that will expand its service offerings and geographic reach.

In return, we offer you

Enjoy endless opportunities to learn, and develop your career in the directions to which you aspire. Philips Healthcare is a place where you will work with others whose far-reaching ideas and accomplishments have impacted over 200 million lives already. Your ideas and ability to deliver will help to transform the future of healthcare, and allow you to create your own legacy.

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 innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.

Visit our careers website to explore what it’s like working at Philips, read stories from our employee blog, find information about our recruitment process and answers to some 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 888-367-7223, option 5, for assistance.

Equal Employment and Opportunity Employer/Disabled/Veteran

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To succeed in this role, you’ll need a customer-first attitude and the following

• Interested in cutting-edge technology and software in the medical device industry

• Has a bachelor/master’s degree in engineering, law, life sciences, pharmacy, medicine, or another relevant discipline

• Quick learner

• Organized, rigorous, committed, and enthusiastic

• Independent and rigorous but still quite creative, flexible, and pragmatic

• Objective-oriented and able to deliver results within the expected deadlines

• Fluent in both written and spoken English

• 5+ years of experience in the medical device industry (EU MDD, Health Canada, China, US FDA class II and/or class III, etc.).

• Strong background in Design Controls.

• Proficient knowledge of medical device regulations (21CFR), FDA law, MDD, other global laws, regulations and standards including ISO 14971, IEC 60601-1 and related particular standards.

• Experience in supporting international registrations and/or clinical investigations.

• Proficient computer skills in Microsoft Office.

• Understand LEAN concepts, methodologies and deployment.

• May require 10% travel annually with possibly some international.