Senior Regulatory Affair Manager

Senior Regulatory Affairs Manager (Contract)

Location: Eindhoven

Duration: 12 months (with possible extension and/or Philips transfer)

Hours/week: 40

Budget range: €4.600 - 6.200 per month

In this role, you will have the opportunity to:

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.

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 labelling and product related marketing communications

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 experience in Regulatory Affairs and Compliance. In total about 10 years of experience in the industry

• You have solid 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;

• A network-oriented mind-set and ability to interact with different business functions at all levels

• 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 have a ditto mind-set

You are a part of

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. And as a YACHT employee, you can expect to receive ongoing support with your personal development and future prospects. 

YACHT provides all employees with a range of benefits, including pension, social security payments and potential to earn a quarterly bonus as well as a mobile and travel allowance.

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.