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Regulatory Consultant Medical Devices
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.
Details
Medical Devices
Netherlands
40 uur per week
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Jouw consultant
Over jouw rol
Zo maak jij het verschil
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.
Wat nodig is
Wat jij mee brengt
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.
Wat wij bieden
Jouw voordelen
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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