Regulatory Affairs Manager

Regulatory Affairs Manager

Location: Best

Contract: Permanent at a Randstad company

Hours/week: 40

Budget range: €4.500 - 5.600 per month

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

In this role, you have the opportunity to make life better through supporting the Personal Health innovation teams in bringing products to the market, complying with external regulations and standards and with company product safety & compliance policies. You will be guiding the business through the regulatory landscape, all within a competitive environment.

In this role you will drive from within R&D that our products meet the Safety, Compliance and Regulatory rules, by checking this with relevant regulations and standards, performance and reliability requirements and Philips policies. You work closely with our central SCR organization.

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:

• Plan, generate, and coordinate regulatory submissions for product licensing per regulatory plan.

• Review development documentation and ensure that the information required for submissions. and product compliance is adequate.

• Review and approve product labeling and product related marketing communications.

Additional responsibilities: 

• Participation in New Product Development Teams (medical device and consumer products).

• Provide Safety, Compliance and Regulatory input in these teams including but not limited to the preparation of Regulatory Strategic Plan.

• Ownership of regulatory submissions such as but not limited to initial registrations, changes/variations, and renewals by:

  • Approbation via coordination of timely preparation of requests for Free Sale Certificates.

  • Work with applicable test houses, notified body and competent authorities.

  • Coordination and collection of specific registration information with R&D, Manufacturing, QA, and applicable departments, as vital to support registration requirements.

  • Assist in the preparation of the Technical File for CE marking.

  • Assist in the preparation of the 510(k) submission and acquire/support clearance in the U.S.

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

• You have a degree in Software, Electrical, Biomedical or Mechanical Engineering, combined with at least 9+ years of experience in Regulatory Affairs and Compliance.

• You have experience with 510(k) submissions.

• Experience with EU and other international medical device submissions as well as in other regulatory domains (consumer products) is a plus.

• Proven analytic capabilities and product knowledge – system thinking.

• Technical writing and project management skills.

You are:

• conceptual, analytical, data driven, and also hands-on, getting things done mentality

• a subject leader and also a team player

• a good communicator skilled in managing interpersonal processes

• quality oriented and solution seeking mind-set.

You are a part of

The Business Personal Health – Mother & Child Care / Womens Health and work in our Research & Development Netherlands organization located in Eindhoven. We develop medical and non-medical products and are responsible for innovation, product research, development, industrialization, and post market activities. You are part of a multidisciplinary organization with over 300 colleagues where the colleagues in Drachten and Eindhoven. We meet in the office an average of 3 times per week in line with our newly-adopted hybrid work concept.

Philips

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.

But it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique individuals, with two things in common. An unwavering sense of purpose and a relentless determination to deliver on our customers’ needs. It’s what inspires us to create meaningful solutions – the kind that make a real difference – when it matters most.

The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.

In return, we offer you:

For this project, you’ll work for Philips and become a contract or permanent employee of YACHT (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.