In this role, you have the opportunity to
Work for a progressive and dynamic multimodality company within the medical device industry in a challenging global regulatory environment, develop and communicate a vision for the RA function to management, including the development of global regulatory strategy in the area of regulatory submission.
As a leader, you will be responsible for managing regulatory team supporting various projects and support Local to local registration in China and support worldwide registrations.
You are responsible for
Managing Regulatory Affairs professionals supporting Philips Ultrasound manufacturing activities in China;
Provide support to programs associated with China manufacturing by developing Regulatory project plans and participates in critical project meetings to provide regulatory guidance on requirements for medical devices;
Responsible for the coordination and preparation of document packages for regulatory submissions from all areas of company, and as needed, participates in internal and external government product audits by various regulatory agencies;
Lead the overall effort associated with product type testing and domestic license registrations with NMPA in China;
Compiles all materials required in submissions, license renewal, initial product reports and annual product reports;
Reviews and communicates requirements for device labeling, and clinical protocols to maintain regulatory compliance;
Responsible for generating, maintaining and keeping abreast of regulatory procedures;
Participates in direct interaction with regulatory agencies on defined matters;
Recommends strategies for earliest possible approvals of device approvals and where applicable, works closely with the Philips China Clinical team on clinical trials applications;
Regulatory Affairs representative for Philips Ultrasound systems and Transducers, 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 supporting domestic registrations in China;
Participates in defect and complaint reviews for program teams, provides guidance to the team on risk assessment and required corrective actions to meet regulatory requirements;
Where applicable, works closely with the Philips Ultrasound Business Group regulatory affairs team from other locations to coordinate and prepare document packages for 510(k) Pre-market notifications to US FDA, Technical Documentation for CE Marketing and global registrations;
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;
Provide leadership and guidance on global compliance, such as CE Marking per MDR and product registrations, clinical evaluations in accordance with MDD/MDR, ISO 13485 and ISO 14155, Canadian CMDCAS, compliance with FDA’s guidance documents etc.;
Manage, mentor and coach regulatory professionals in their development;
You are a part of
You are a part of Philips Ultrasound Regulatory Affairs team based in China. You will report to Philips Ultrasound Regulatory Affairs Organization. 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.
Minimum of 15 years of experience in a medical device company (FDA Class II and Class III and MDD/MDR).
First line experience with FDA and MDD is required
Management experience is required.
Team player who can work in a matrix environment with employees in different locations
International experience is a requirement
Experience with CT Imaging systems is preferred
Must have experience with successful preparation and submission of Design Dossiers, 510(k), PMA, Technical /Design Dossiers 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 20% local travel annually and some international travel
In return, we offer you
We welcome you to a challenging, innovative environment with great opportunities for you to explore.
Our benefits are very competitive and designed around your preferences:
A market conform salaryAnnual paid leave
A variable bonus based on both Philips results and personal performance
Extensive set of tools to drive your career, such as a personal development budget, free training and coaching
Solid company pension scheme and attractive collective health insurance package
Opportunity to buy Philips shares and products with discount
Healthy work-life balance
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 at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . 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 at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech/philips-recruitment-process.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .