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Medical Device Regulatory Specialist

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The company

Our client is a professional Pharmaceutical, FMCG and Medical Devices organisation, based in West-Vlaanderen Belgium. This organization is internationally represented. They are one of the market leaders for the development of self-care products. They offer an extensive product portfolio and rapidly expanding.

Role description

In your role as Regulatory Affairs specialist, you will gain the responsibility to collect, maintain and adjust technical files and relevant documentation. You will have a supportive role in creating awareness and exchange of knowledge about international regulations and changes. In addition, you interact with internal and external stakeholders and you will ensure that they are provided with the required information. Next to that, you are involved in the development of strategic plans which are related to the Regulatory Affairs and the implementation.

Responsibilities

On a daily basis you are responsible for the collection and implementation of regulations in relation to the specification of various products. Furthermore, your tasks include:
• Active role in maintenance and (new) product registration for particular foreign markets
• Supportive role for both internal and external stakeholders about RA related topics
• Development and assessment of the documentation database
• Development and adjustment of strategic plans and assessment of procedures for verification and validation projects
• Supporting execution of evaluation and risk management procedures
• Application and implementation of international legislation and documentation

Requirements

• Bachelor or Master
• Minimal 3 years of experience in the Medical Devices, pharmaceutical or cosmetics sector
• Minimal 1-2 years of experience in a RA role
• Preferably knowledge of the Medical Device Directive or Medical Device Regulation
• Excellent writing and verbal skills in English
• Preferably knowledge of GMP, GDP, ISO 13485, particularly the 2016 norm
• Strong analytical skills and eye for detail
• Team player, yet individual operator

Other information

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Ewout de Jong.


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SIRE Life Sciences®

Listed by: SIRE Life Sciences®
Listed on: 17-06-2019
Country: Belgium
Region: West-Vlaanderen
Employment: Permanent
Expertise: 3 - 5 years
Location Type: On location
Education: Master
Language: English
Sector: Medical Devices
Specialisation: Regulatory Affairs

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Contact

SIRE Life Sciences B.V.

Mondriaan Tower
Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 20 658 9800

SIRE Life Sciences Deutschland GmbH

Fünf Höfe
Theatinerstraße 11
80333 München
+49 (0) 89 3803 8966

SIRE Life Sciences UK

702 Howard House Dolphin Square
SW1V3PQ London
+44 7307 179882

SIRE Staffing Solutions B.V.

Keizersgracht 440A
1016 GD Amsterdam
+31 (0) 20 658 9804

SIRE Life Sciences Consultancy B.V.

Wetenschapsstraat 14B
1040 Bruxelles
+32 (0) 2 588 1277