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Regulatory Consultant Medical Devices

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17 JAN '23: This organisation was founded in 2011. Though young and dynamic, the consultancy embodies decades and decades of experience. Not only do they have regulatory expertise in both product development as well as maintenance, but they also are strong when it comes to pharmacovigilance. Rather than performing a task, they work with clients proactively to bring business to the next level. They value a personal approach with attention to their clients' needs.


Medical Devices

Oss - Netherlands

40 hours per week

QTC logo icon About your role

This is how you will make the difference

As a Regulatory Consultant Medical Devices, you ensure compliance of documentation and QMS with the relevant ISO standards, Directives, Regulations and Guidance Documents. For medical devices, combination/borderline products or IVDs. Whether it concerns ISO 13485 auditing, writing and composing technical files or managing the approval process with the notified bodies; You work in a team with the experience and dedication to support the customer. You value a personal approach with attention to the client's needs. Furthermore, you will work on the following: CE classification, Competent authorities interactions, ISO 13485 QMS, Regulatory strategy plan and MDR gap analysis.

QTC logo icon what's needed

What you bring

You are a good resource that start-ups or other organisations can rely on. In addition, you are a team player who can share his/her knowledge with colleagues to work together and deliver the best service to the customer. What else is requested within this role:
  • have an MSc/PhD in Pharmacy, Chemistry, Medical Biology, Life Sciences;
  • will prepare and update technical documentation (eg. STED, BSER, CER, RMP);
  • will coordinate and manage interactions with notified bodies;
  • implement and maintain ISO 13485 quality management systems;
  • perform IVD and medical device directive vs. regulation gap analysis.

QTC logo icon What we offer

What's in it for you

This organisation offers you the opportunity to build a large network within the medical devices industry. In addition, you will be trained if necessary to further develop yourself as a Consultant in the field of Regulatory Affairs within the medical devices industry. Furthermore, they offer the following:
  • A competitive salary;
  • Laptop and company phone;
  • 25 holiday days;
  • Pension.

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