Regulatory Affairs Manager

Regulatory Affairs Manager

Location: Best, Netherlands

Duration Assignment: 12 months (with possible extension)

Contract: via a Randstad company

Hours/week: 40

Monthly Salary: €3,892 - €5,372

In this role, you have the opportunity to:If you have proven experience with successful preparation and submission of 510(k) and are ready for a new challenge, this role is for you! As a Regulatory Affairs Manager, you will provide strategic input during the product creation process and develop the overall regulatory strategy plan. You will work closely with Product Development, Medical/Clinical Affairs, and Marketing and Sales to drive successful submissions and compliance.

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:

• Developing and influencing global regulatory policy across diverse product categories (implants, software, combination products, biologics).

• Leading regulatory affairs projects and overseeing content for FDA, EU, CA, and other global regulatory submissions (Pre-submissions, IDE, 510(k), Technical Files/Design Dossier).

• Coaching and developing RA project team members to enhance their skills and performance.

• Providing strategic guidance to ensure compliance and successful market entry of new products.

• Collaborating with cross-functional teams to drive product introductions, maintenance, and process improvements.

• Applying advanced analytical skills to develop innovative solutions and strategies.

• Building and maintaining strategic partnerships with internal and external stakeholders.

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

• Bachelor’s/Master’s degree in Science.

• Minimum of 5 years of experience in medical device regulatory strategy and product market introductions.

• Proven experience in regulatory submissions, including successful preparation and submission of 510(k) and global registrations.

• In-depth knowledge of FDA, EU, and Health Canada regulations.

• Experience with medical devices and software (required), artificial intelligence (preferred).

• Strong project management and planning skills.

• Excellent communication and interpersonal skills in English.

• Ability to work independently and as part of a team in a dynamic environment.

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.

Are you ready to take the next step?