Make the difference as a

Regulatory Affairs Manager Digital

Within our Digital & Innovations team, we are looking to recruit a Regulatory Affairs Manager with a digital focus. Our global operating team consists of Product Owners, Solution Specialists and Developers.

What are you going to do?

Mediq has been developing digital services (including apps and platforms) for a number of years to allow patients and care providers to connect more closely with us. For example care monitoring and or the digital support for chronically ill people in the broadest perspective. Working with solutions for patients and patient data requires meticulous quality assurance and recording of essential reports. Referred to in the jargon as regulatory compliance. Our healthcare landscape is experiencing rapid growth, partly due to technical developments, but also due to Covid and regulations. Due to these developments, innovation in healthcare has turned out to be of significant importance, which will continue to give further developments by Mediq a boost. The international collaboration within Mediq and the further development of digital propositions require solid regulatory compliance. Your role is an essential part in the team of product owners, solution specialists and developers. As a result, with every innovation, compliance with international standards and essential requirements is kept in scope and also recorded. The RA and QA process will be improved by you within the team and secured in the organization. You provide support to the team in all leading RA and QA activities.

What is your background?

• A relevant education at university level.

• Both excellent Dutch and English language skills

• You are familiar with file formation and you have insight into what is needed to comply with all the regulations and laws.

• You have experience with writing technical files

• You have experience with risk management within the digital domain (preferably also in the medical domain)

• You have experience with or have been involved in software development (apps & platforms)

• You have experience with data, security and privacy

• You have an affinity with innovation in healthcare

• You have an affinity with digital innovation in healthcare and you have experience with software development.

• It is an big advantage if you have experience in working with notified bodies, and/or have knowledge of MDR regulations

• Finally, you have an affinity with software development and digital innovation

De Meern

De Meern

At our head office in the Meern, we lay the foundation for good service to our customers. From De Meern we have contact with all customers, suppliers, but also the government and insurers. Every day thousands of customers are helped and informed from De Meern. With the large Customer Contact department, De Meern is the beating heart of our organization. De Meern is also the (international) headquarters of Mediq. In De Meern you will find Mediq's group management and international staff departments, including for example finance and IT. Finally, in De Meern you will find the management of the Mediq Netherlands organization and the Dutch staff departments such as finance, HR, communication and quality. The nice thing about working at De Meern is that you work at Mediq's head office, where everything comes together. You get to know about 500 different employees and all aspects of our business here.
About Mediq

About Mediq

Our story is not just about ourselves. It is mainly about the millions of people who deserve the opportunity to get the most out of their lives. Fathers and mothers. Brothers and sisters. Young lovers and old friends. Grandparents and newborn babies. They have one thing in common: they have been diagnosed with a chronic or serious disorder. Mediq has activities in the Netherlands, Denmark, Germany, Norway, Sweden, Finland, Hungary, Switzerland, Belgium, Estonia, Latvia and Lithuania.

Application process

1
Online application
Complete your profile, upload your cv and add your motivation
2
Screening
Your application will be reviewed, where applicable we may check your professional qualifications
3
1st interview
You get to know Mediq and we get to know you
4
2nd interview
Together we will dive deeper into the job and how that matches up with your talents.
5
Offer
If you and we are enthusiastic about the match we have, we make you a good offer.
6
Welcome to Mediq!
You have a new job and we love to welcome you to Mediq!

Apply for this job

Apply now if you're interested in this vacancy! Make sure you have the following documents ready to add to your application.