Regulatory Affairs Project Manager

Medical Devices

You bring clarity to a world full of rules

Apply now

Regulatory Affairs Project manager Medical devices

You bring clarity to a world full of rules

Regulatory Affairs Project manager

Medical devices

You bring clarity to a world full of rules

Hengelo

24-32 hours

100 colleagues

>250 products

Your responsibilities

Your expertise makes regulations understandable

As a Regulatory Affairs Project Manager, you are responsible for leading regulatory projects of varying size and complexity. You oversee the entire project process - from initiation to completion - and ensure effective planning, progress monitoring, coordination, and communication. You work closely with various departments and customers and translate regulations into concrete actions and project results.

 

Based in Hengelo, where the Regulatory department is located, you will maintain close contact with colleagues and management at other locations.

Duties and responsibilities

  • Leading regulatory projects from start to completion, including scope, planning, budget, risks, and communication.
  • Drawing up, monitoring, and adjusting project plans, priorities, and budgets.
  • Ensuring timely, careful, and efficient execution of work by the project team.
  • Acting as the first point of contact for internal and external stakeholders.
  • Monitoring progress, quality, and budget, and escalating issues in a timely manner where necessary.
  • Identifying deviations and implementing corrective measures.
  • Building and maintaining customer relationships.
  • Coordinating multidisciplinary input from different departments.

You know how to translate complex regulations into clear, actionable steps for the project team and ensure that all departments involved, from R&D to Design Transfer to Sales, know exactly what is expected of them.

 

In addition to project work, you actively contribute ideas for improving internal processes. You share knowledge through presentations and reports, contribute to the development and improvement of templates and tools, and help make our project methods increasingly smarter and more efficient.

You bring clarity in a world full of rules

You bring

  • HBO/WO degree in a relevant scientific field
  • Broad knowledge of regulations concernig medical devices
  • Demonstrable experience in leading regulatory or multidisciplinary projects
  • Familiar with project management methodologies and tools, Word and Excel
  • Strong communication skills; customer-focused and persuasive
  • Good command of spoken and written Dutch and English

You receive

  • Competitive full-time salary between €4,331.00 and €6,615.00 (based on your education and work experience)
  • A one-year contract for 24-32 hours with the prospect of permanent employment if you perform well.
  • Pension accrual with ASR
  • Option to work from home one day a week, in consultation
  • Travel allowance
  • On-the-job training opportunities
  • Training opportunities and coaching on technical and personal development.

Ready to build the medical technology of tomorrow?

The Regulatory team consists of 6 colleagues. You will regularly consult with the Regulatory Manager about your performance and project progress. You will coordinate your planning and priorities with other project managers to ensure that activities are well aligned. You will also be in contact with colleagues in other departments and know how to connect people. You will discuss project results, files, and design or compliance issues with customers and external parties. You ensure an open flow of information and encourage effective collaboration.

Unitron works closely with customers on a wide range of products, from concept to certified medical device. The culture? Dynamic, innovative, and built on collaboration. Here, we combine pragmatic solutions with high-tech expertise to push boundaries together.

Apply now and become part of our team of passionate professionals. Together, we are committed to delivering innovative solutions in medical technology.


Leave your details with us. We will contact you within three working days to get to know you and hear about your ambitions. We hope to hear from you soon.

 

Would you prefer to conctact us by phone or email first?

Please contact Corine or Gillian from HR

  • 0117 307 300 | ✉️hr@unitron.nl
Apply now 

From idea to innovation

About Unitron

We believe in healthcare where patients receive optimal care thanks to the best technology and where medical professionals use high-quality instruments to provide the most successful treatment.


With more than 100 professionals, we work at three locations on high-end life science products, from design to realization. We develop medical devices for fields such as anesthesia, oncology, and diagnostic imaging. Our strength lies in complex mechatronic and electronic equipment and techniques.


Our ambition is to grow. With colleagues who also get excited about the latest technical developments. And who, like us, are eager to use their problem-solving skills to create a better medical world. Will you join us?

"Working with colleagues here is very pleasant. Everyone is willing to contribute ideas. Throughout the company, the lines of communication are short and there is no hierarchy: everyone is equal. That makes it easy to switch gears quickly and come up with the best solutions together."

— Robin de Jaeger, Support Accountmanager

Apply now

Do you want to use your talent to improve the lives of patients?

Then leave your details here. We will contact you within three working days to get to know you and hear about your ambitions. We hope to hear from you soon!

Would you prefer to contact us by phone or email first?

Contact Corine or Gillian from HR:
0117 30 73 02 | c.dekker@unitron.nl
0117 30 73 20 | g.jones@unitron.nl

Curious about the other roles?

Meer weten over Unitron?

www.unitron.nl