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In this role, you have the opportunity to

Work for a progressive and dynamic company within the medical device industry in a challenging global regulatory environment, develop and communicate a vision for Regulatory Affairs excellence, including the development of global regulatory strategies in the area of regulatory submission.

You will prepare comprehensive regulatory strategies for complex devices and post market changes. Clearly communicates strategies to Regulatory Affairs management, project teams, and business unit leadership. Preparing regulatory filings for products, as well as post market changes. As necessary, reviews complex regulatory issues with Regulatory Affairs management.

You are responsible for

• 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;

• Able to identify risks within regulatory strategies, project plan, and outline proposal for balancing the project risks to projects teams and RA management;

• Professionally negotiate directly with regulatory enforcement entities (e.g. governmental agencies, notified bodies, etc.) on regulatory filings at the reviewer level. All significant issues will be reviewed with the RA management;

• Driving improvement in regulatory aspects of the Quality Management System and in developing processes and documenting procedures to ensure an effective Quality System is maintained;

• Providing guidance on global compliance, such as CE Marking and product registrations, clinical evaluations in accordance with MDD Annex X, ISO 13485 and ISO 14155, China NMPA, Japan JPAL, compliance with FDA’s guidance documents, and including requirements that are relevant to the overall Philips medical device priorities globally;

• Ensuring compliance with the current regulatory procedures and where needed, generate new and/or update procedures when new regulatory requirements are determined to go into effect;

• Providing regulatory support for (pre-) clinical studies, including recommending strategies to optimize clinical study approvals and review of clinical study protocols;

• Where applicable, represent Philips in an international committee chartered to develop an applicable standard;

• Mentor and coach Philips medical device regulatory professionals in their development;

You are a part of

You are a part of Philips Emergency Care and Resuscitation (ECR) Regulatory Affairs Organization with a global footprint. The Regulatory Affairs team is multicultural and are enthusiastic professionals that work as a team to ensure regulatory compliance.

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

• Bachelor/Master of Science degree in a technical or business discipline;

• 9+ years of experience in a medical device company;

• First line experience with US FDA and EU MDD is required;

• Understands the requirements surrounding EU MDR requirements;

• Maintains detailed knowledge on the subject of ISO 13485 and QSR requirements;

• Experience surrounding international regulatory submissions and registrations is required;

• Must have experience with successful preparation and submission of Technical Documentation, 510(k), De Novo, PMA, and registrations of medical devices globally;

• Experience with Software as Medical Devices, and defibrillator/monitor devices is preferred;

• Team player who can work in a matrixed environment with teams in different locations;

• 10-15% of travel may be required;

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 .

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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