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Regulatory Affairs professional

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The company

Our client is a professional Medical Devices organisation, based in Vlaams-Brabant Belgium. This organisation is an innovative and rapidly growing Medical Device company. They are internationally represented and are currently expanding their markets.

Role description

In your role as Regulatory Affairs consultant, you will receive the responsibility to support and guide a project with the FDA. You will assist the team, other departments and external stakeholders. You will overview the documentation, participate in inspections, submissions and registrations. Next to that, you are involved in the development of strategic plans and the implementation.

Responsibilities

• Key role for Regulatory Affairs for internal and external stakeholders among which authorities and notified bodies
• Support in the administration, submissions and registrations of product documentation
• Supportive and advisory role for the particular project
• Maintenance and controlling of the required regulation standards and legislation
• Leader during internal and external audits from the beginning to the end of the process, and making reports of these audits

Requirements

• Bachelor or Master in Life Sciences
• Experience with the MDD and preferably MDR
• Excellent knowledge of CE-marking, FDA and 510 k. Submission
• Experience with inspections, support in audits for both internal and external suppliers
• Excellent writing and verbal skills in English
• Knowledge of the ISO 13485, particularly the 2016 norm
• Strong analytical skills and eye for detail

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: 24-04-2019
Country: Belgium
Region: Vlaams-Brabant
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 Belgium BVBA

Science 14 Atrium
14b, Rue de la Science
1040 Bruxelles
+32 (0) 2 588 1277

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 Life Sciences Maastricht

ROOOMS Maastricht
Boschstraat 21
6211 AS Maastricht


SIRE Group GmbH

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6039 Root
Luzern
+41 (0)43 508 1743

SIRE Staffing Solutions

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1016 GD Amsterdam
+31 (0) 20 658 9804

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3012 CC Rotterdam
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SIRE Healthcare

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Amstelplein 52, 25th floor
1096 BC Amsterdam
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SIRE Human Resources

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+31 (0) 85 044 4620

SIRE Staffing

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Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 85 044 4650