21CFR820 Regulatory Affairs Specialist

Regulatory Affairs Specialist (Contract)

Location: Netherlands

Duration Assignment: 6 months

Contract: via a Randstad company

Hours/week: 40

Monthly Salary: €3,892 - €5,572

In this role, you will have the opportunity to: Make life better!In this role, you challenge yourself as a Regulatory Affairs Specialist by supporting new project introductions, managing regulatory submissions across key markets (FDA, Health Canada, EU, etc.), and contributing to strategic regulatory planning in a high-performing, globally distributed team within Image Guided Therapy Systems (IGT-S).

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:

• Providing strategic regulatory input during the product development process.

• Supporting development of departmental regulatory strategy plans.

• Managing product registrations and approvals across global markets including FDA, MFDS, NMPA, EU, and others.

• Keeping current on regulatory procedures and changes to ensure ongoing compliance.

• Playing a key role during external audits and notified body inspections.

• Reviewing and recommending updates to labeling and design documentation.

• Reporting on global regulatory roadmaps and aligning them with marketing and product strategies.

• Acting as a regulatory ambassador, upholding Philips values and compliance standards.

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

Technical Competences:

• Proven experience in regulatory affairs for medical devices, including global submissions (FDA, Health Canada, EU MDR, etc.).

• Experience with regulatory documentation and labeling reviews.

• Deep understanding of global regulatory and legislative initiatives.

• Knowledge of product lifecycle management and post-market compliance.

Behavioral & Management Skills:

• Strong communication and stakeholder management skills.

• Ability to work in a fast-paced, culturally diverse global environment.

• Comfortable navigating audits and regulatory inspections.

• Process-oriented with a proactive mindset.

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.