Junior Regulatory Documentation Coordinator

Junior Regulatory Documentation Coordinator (Contract)

Location: Best or a hybrid is an option (Need to be in the office on Tuesday & Thursday)

Duration Assignment: 12 months (with possible extension)

Contract: via a Randstad company

Hours/week: 40

Budget range: €3.836 - €4.600 per month

In this role, you will have the opportunity to: Make life better!

Provide input for regulatory strategy during the product creation process and contribute to the department's overall regulatory strategy plan. You will be responsible for coordinating documentation, i.e. collecting signatures, printing documents 

When you choose to work at Philips you’ll work on life-changing projects; and contribute to innovative health technologies and solutions that improve billions of lives around the world.

You will be responsible for: 

• Coordinating all the paperwork to be signed off 

• Data entry 

• Work according to the business applicable processes and as ambassador of the Philips values.

• Keeps abreast of current regulatory procedures and changes

• Key role in external and internal audits related to product submission such as FDA, MFDS, NMPA etc. and notified body audits.

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

• Responsible for developing and implementing global regulatory and roadmaps though deep understanding of the competitive market landscape , regulatory/ legislative initiatives, and product marketing strategy for their responsible products within IGT-S Fixed portfolio

• Responsible for product registrations/approvals in her/his field.

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

You will need a customer-first attitude and the following 

• Minimal of 1 years of experience in the medical device industry and knowledge of regulatory affairs

• Must have experience with successful preparation and submission of international documents or registration and marketing of medical devices worldwide

• Strong mindset towards documentation

• Experience in supporting international registrations and clinical investigations

• Bachelor's degree in a technical/quality/law/pharma discipline

• RAPS certified (as a plus)

You are a part of

A team of Regulatory Affairs Specialists based in Best (IGT-S). 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.

In return, we offer you:

For this project, you’ll work for Philips and become a contract or permanent employee of a Randstad company. As a contractor at Philips you'll enjoy cutting-edge challenges and unexpected experiences that make you a more in-demand professional.

Why work on a project at Philips?

If you’re looking for meaningful work and a chance to tackle complex challenges, broaden your skills and expertise and become an even more sought after professional, you’ll find all that and more with project work at Philips.

The Randstad companies are responsible for finding talent to provide services at Philips. If you are selected to provide services for Philips, you will be employed by Randstad and will not be an employee of Philips.