Job Title

Job Description

In this role, you have the opportunity to:
 

• Participate in and advise cross-functional team on the applicable requirements for remediation per EUMDR regulation;
• Review the existing and/or improved protocols and reports to ensure the information required for EUMDR tech file is adequate;
• Review and approve product labeling and marketing promotional materials for the responsible products；
• Plan, generate and coordinate the EUMDR tech file, FDA 510(k) and other submission dossier for a timely submission;
• Maintain and update the regulatory licenses per the change control processes.
• Establish, maintain and implement policies and practices related to creating and maintaining an active involvement in the legal and regulatory processes of covered Competent Authorities

You are responsible for:
 

• Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, Agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives.
• Create detailed written regulatory plans that will be used to target domestic and international shipment dates.
• Develop and prepare product registration submissions for worldwide locations.
• Review and approve advertising, promotional items and labeling for regulatory compliance.
• Identify potential regulatory approvals risks based on changes in regulations, standards country specific issues or other unique characteristics of the project.
• Communicate application progress to internal stakeholders
• Collaborate with worldwide colleagues regarding license renewals and updates
• Maintain regulatory files and tracking databases as required
• Communicate with regulatory agencies as needed
• Mentor other regulatory affairs personnel within DCS

You are a part of

GSC China, Q&R

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

• Bachelor’s degree or equivalent internationally-acquired qualifications preferably in Regulatory Affairs and/or a science related field or equivalent experience in the medical device industry
• 5 + years of regulatory approvals and submittal experience (EU MDD, Health Canada, USA, etc.)
• Must be able to manage multiple tasks and perform with accuracy and a high attention to detail
• Requires strong written, oral and interpersonal skills to be able to effectively compose agency submissions, interface interdepartmentally and complete assignments with minimal supervision
• Proficient knowledge of domestic and international standards and regulations
• Experience with FDA 510(k) submissions preferred
• RAPs RAC preferred
• Understand LEAN concepts, methodologies and deployment
• May require 10% travel annually with possibly some international

In return, we offer you

A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this market-based role in a complex environment will open many doors for your long term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities.

•           A professional but fun workplace, a healthy work-life balance environment;

•           An energetic, genuine, inventive, supportive and dynamic team atmosphere;
 

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.