Regulatory Affairs Specialist


About this job

  • Branche: Medical devices
  • Area of expertise: Regulatory
  • Location: Noord Brabant

What is required?

  • Hours per week: 40
  • Education level: Professional Bachelor
  • Closing date: Friday, July 2, 2021

About this role

You will be a team member of the global regulatory organization and will be reporting to the Regulatory leader. The team you will be working in, is a high-performance, culturally diverse, and very dynamic team.

Support the running projects in worldwide submissions , drive under supervision of the RA core team member the prioritized countries by being the linking pin between core team and the RA leads in the countries. Therefore knowing and experience with rest of world submission or supported a US(510k)/EU(STED) submission is a must
The Regulatory Affairs Specialist works mostly with countries all over the world on the International registrations and support in special actions like CAPAs. This can be a person who is looking to get a better understanding how Regulatory works in the international market(outside of EU, USA, Canada and Japan).

You are responsible foro Work according the business applicable processes and as ambassador of the client values.
o Works with the RA Project Leads/RA Seniors to get the required information to get clearances for the products that are changed or released towards the markets.o Takes lead for RA CAPAs and support the RA team to close CAPAs
o Support development of the regulatory plan, guidance on risk assessment, and required corrective action to meet regulatory requirements and product registrations such as, but not limited to , CE marking and clinical evaluations.o Develops and facilitates regulatory submissions, for new product/solutions existing products/solutions in the international markets.


To succeed in this role, you should have the following skills and experienceo Bachelor’s degree in a technical/quality/law/pharma discipline
o 1-4 years of experience in the medical device industryo Goal oriented, reliable, and extremely well organized with strong attention to detail.
o Demonstrates ability to work independently and work through projects with minimal supervision.o Affinity with medical device regulations (21CFR), FDA Law, MDD, other global laws and regulations is a plus.
o Familiarity with preparation and submission of 510 (k) , PMA or international documents or registration and marketing of medical devices worldwide is a plus.


Brunel offers outstanding individuals a highly diverse and challenging job opportunity in a company where an open, professional and pleasant working culture is greatly valued; where your personal initiatives will be noticed and rewarded; and where you will receive all the support, coaching and training you need for your future career. This is your opportunity to discover a wide range of sectors and activities and develop your expertise in a fast-moving and results-oriented environment. Being intermediated by Brunel means that you are contracted by Brunel. Not only you will have a contract, you will as well be assured of a great career! Our primary and secondary terms of work are excellent. A few examples are price reductions at CZ Health Insurance, bonus opportunities and standard 26 days off. Brunel Engineering intermediates both junior and senior engineers within the industry for over 45 years now. Our clients vary from multinationals to local companies. Together we will find the job which meets your wishes.

Join the Brunel Community

With a century of history and more than 450 innovative products and services, our client is ready to meet today's challenges within healthcare. They do this by creating solutions to provide better care to more people, at lower cost.
Their more than 12,000+ employees, working in countries worldwide, are dedicated to helping you create meaningful moments of care.

Start applying immediately

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Any questions remaining?

Your consultant, Johan Martin de Vries is happy to clarify anything about this vacancy. When reaching out, use the pub number:

Account manager

Johan Martin de Vries
Brunel Netherlands Eindhoven
+31 40 257 8015

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