Regulatory Affairs Manager – In Vitro Diagnostics – Belgium
Mackenzie Stuart are currently representing an innovative In-Vitro Diagnostic multinational that focus within the Infectious Disease market. Due to the company’s recent expansion across Europe the need for a Regulatory Affairs Manager has arisen to be based at the companies main R&D facility in Belgium. This role would be responsible for leading projects for new and existing products to minimise time to market whilst also being responsible for ensuring all technical aspects of the product design is maintained.
- Responsible for maintaining product compliance with the FSA & CLIA requirements for IVD devices
- Fully responsible for ensuring US regulatory requirements are clearly identified and implemented
- Prepare and submit regulatory submissions for new products
- Responsible for negotiating with regulatory bodies for marketing authorization
- Provide feedback and technical advice to product development teams
- BSc educated in Scientific subject
- Experience within R&D is desirable
- Working experience with regulatory bodies such as FDA
- Strong background within the IVD market
- Fluent in English
- Strong both verbal and written communication skills
This is an excellent opportunity for a relevantly educated and experienced individual looking to enhance their career. If you feel you would be suitable for this role then please apply below, candidates without the necessary requirements need not apply.
About Mackenzie Stuart;
Mackenzie Stuart is an executive search and selection company working globally in many different sectors. From out offices in Leeds we provide retained and contingency recruitment solutions across industry and have specialist, experienced recruitment consultants that work within Medical & Scientific, Oil & Gas, Mining, Legal, and Construction.
Job Reference: LS-DS-264
€50,000 - 80,000