Regulatory Affairs Specialist

Regulatory Affairs Specialist (Contract)

Location: Best

Duration Assignment: 6 months (with possible extension and/or Philips transfer in time)

Contract: Permanent at a Randstad company

Hours/week: 40

Budget range: €3.500 - 4.900 per month

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

You are working on regulatory submissions for new products and existing products. With your contribution you help Philips to do product registrations on a global scale. 

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:

• Develops and facilitates regulatory submissions, for new products/solution, existing products/solutions.

• Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, Agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives.

• Create comprehensive regulatory strategies.

• Develop and prepare product registration submissions for the US, Canada, EU and support worldwide international submissions as assigned.

• Review and approve advertising, promotional items and labeling for regulatory compliance.

• Identify potential regulatory approvals risks based on changes in regulations, standards country specific issues or other unique characteristics of the project.

• Communicate application progress to internal stakeholders.

• Collaborate with worldwide colleagues regarding license renewals and updates.

• Communicate with regulatory agencies as needed.

• Support the site audit for the responsible products, including NB surveillance audit, FDA inspection, MDSAP audit, and all kinds of unannounced audits etc.

• Provide audit, CAPA and post market regulatory support as assigned.

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

• Bachelor’s degree required in a technical discipline.

• A minimum of 6 years of experience working in Regulatory Affairs within a medical device industry.

• Proficient knowledge of medical device regulations minimum FDA and Canada, worldwide is desired. Must have personal experience with successful preparation and submission of 510(k) submissions.

• Able to work effectively with minimal supervision.

• Proficient knowledge of domestic and international standards

• Strong background in Design Controls.

• Experience in supporting international registrations and/or clinical investigations.

• Experience with Software Medical Devices strongly preferred.

• Proficient computer skills in Microsoft Office Suite

• Understand LEAN concepts, methodologies and deployment.

• Requires strong written, oral and interpersonal skills to be able to effectively compose agency submissions, interface interdepartmentally and complete assignments with minimal supervision.

• High efficiency on problems solving from RA perspective;

You are a part of

You will be part of the Regulatory Affairs team for our Diagnostic X-Ray unit within Precision Diagnosis business and therefore, influence and shape the regulatory capabilities for future success of Philips. This hybrid role is based in our Best office in the Netherlands.

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.