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Regulatory Affairs Manager
Location: Benelux
Salary: Competitive
Duration: Permanent 

Are you looking for an exciting opportunity and have a passion for working within Regulatory Affairs in addition to use your language skills? An unique opportunity has arisen with an International Medical Devices company based within the Benelux. This position as a Regulatory Affairs Manager offers the opportunity to join the biggest Medical Devices Regulatory Affairs Consultancy company based in the heart of Europe.

Responsibilities:

Regulatory Affairs Management for Europe and US markets
Guiding the company through FDA inspections as well as MDD 21/42/EEC
Responsible for overseeing all matters of compliance – CE mark and CAPA
Regulatory Affairs and Quality Assurance through pre-market and post-market
Being involved in clinical trials from an RA perspective
US and EU submission
Developing outstanding regulatory services and leadership to Flemish and Dutch speaking clients accounts
Establish efficient communication networks with the business partnerships across the globe
Quality Assurance experience within the Medical Devices sector is highly recommended

Qualifications/experience required:

•             A degree level in Engineering, Pharmacy, Medicine or Life-Science
•             Experience in Regulatory Affairs – preferable within Implantable sector
•             Global product submission such as 510K is essential
•             Knowledge of EU directive and guidelines
•             Knowledge of health authority submissions 
•             Experience in RA and QA within Benelux
•             Strong knowledge of Belgium and Netherlands regulations
•             Fluent English with Dutch/Flemish to mother tongue standard is essential

If you are interested please contact:

Yasmina Mallem on +32 (0) 2 892 3993 or Yasmina.mallem@clinicalprofessionals.eu

If however, you do not feel that this is the right role for you, please forward these details on as we have a generous referral scheme in place.
Please note due to the high level of applications if you are not contacted within 48 hour, you have not been successful on this occasion.

Key Words: Regulatory Affairs, PMA, 510K, post market surveillance, vigilance reporting, labelling, risk management, Dutch, Flemish, French, Benelux, Belgium, Netherlands, Medical Devices, implantable devices, Quality Assurance, QA, RA, orthopaedic, wound care, endoscopy, consultancy, notified body, audit

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