null

In this role, you have the opportunity to

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 per MDD and MDR, 510(k).

You are responsible for

• Supporting compliance with EU MDR activities including updating the Technical Files

• Responsible for key program/project deliverables by developing Regulatory project plans

• Participates in program/project meetings to provide guidance on the world wide regulatory requirements for medical devices

• Responsible for product registrations/approvals

• Coordination and preparation of document packages for regulatory submissions from all areas of company, and participates in external government product audits by China, Korea, Japan and other inspection agencies as needed

• Compiles all materials required in submissions, license renewal, initial product reports and annual product reports

• Reviews and recommends changes for labeling, and clinical protocols so as to maintain regulatory compliance

• Keeps abreast of current regulatory procedures and changes

• Participates in direct interaction with regulatory agencies on defined matters. Recommends strategies for earliest possible approvals of clinical trials applications

• Regulatory Affairs representative for the CT/AMI Systems and assists with regulatory issues related to such items as labeling and marketing ideas, claim development and prepares documents required in the Development Life Cycle, and recommends strategies for most efficient and effective approvals of regulatory applications for a program.

• Defect and complaint reviews for program teams, provides guidance to the team on risk assessment and required corrective actions to meet regulatory requirements

• Responsible for the coordination and preparation of document packages [510(k) Pre-market Notifications, Technical File and Design Dossiers for CE marking, initial product reports and annual Reports for regulatory submissions

• Drives improvement in regulatory aspects of the Quality System, developing processes and documenting procedures to ensure an effective Quality System. Reviews and recommends changes for design process and manufacturing procedures to maintain quality and regulatory compliance

• Key role in external audits related to product submission such as FDA, 3rd party external regulatory agencies like SFDA, KFDA, JPAL, etc. and notified body audits

• Implements internal or external quality system audits

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

• Bachelors of Science degree in a technical or business discipline

• Minimum of 5 years’ experience working with regulatory and safety standards (e.g. IEC 60601-1, IEC 62304, ISO 10993-1, etc.) to support product registrations including NB audits

• Minimum of 5 years of experience in a medically regulated and technical environment

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

• Knowledgeable of ISO13485 and QSR requirements

• Excellent working knowledge of medical device regulations (21CFR), FDA law and CE marking

• Experience in supporting international registrations

• May require 10% travel annually with possibly some international

You are a part of

Global Regulatory team, part of CT/AMI Q&R organization.

In return, we offer you

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.

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 .

#LI-EU