27 FEB '23: This organisation is a leading consumer health company dedicated to providing innovative solutions to support individuals in their journey towards better health and wellness. With a focus on quality and effectiveness, their products are designed to meet the diverse needs of consumers across the globe. Though young and dynamic, the organisation embodies decades of experience.
Dongen - Belgium
40 hours per week
Get to know
Mark Breed+31 6 30 28 72 04 email@example.com
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 or combination/borderline products. 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.
What you bring
You are a good resource that that the organisation 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.
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 car and phone;
- 25 holiday days;
Send your application