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Regulatory Affairs Manager

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The company

Our client is a professional Pharmaceutical, Medical Devices and Finance organisation, based in Brussels Hoofdstedelijk Gewest Belgium. This organisation contributes to the improvement of high- quality, however accessible and affordable, global healthcare. They focus on the development of technologies to improve clinical care, invasive and general surgery.

Role description

In your role as Regulatory Affairs manager, you will be completely involved with creating strategies and developing plans to make sure that products are compliant in relation to required documentation and legislation for Europe. You will lead various types of audits among which internal, and distributor audits. You will lead your team in acting up on these audits, performing CAPA’s and creating tools for compliancy. Next to that, you will be the key person to contact for the establishment and maintenance of relationships with internal and external authorities.

Responsibilities

• Key contact person concerning Regulatory Affairs for internal and external stakeholders among which authorities and
notified bodies
• Creating awareness and spread of knowledge regarding RA related topics and procedures
• Supportive and advisory role as team lead, and for subsidiaries of the organisation
• Overviewing the ongoing changes and points of improvement for the Quality Management System and relevant, required
documentation
• Maintenance and controlling of the required regulation standards and legislation
• Follow up on the latest developments for Medical Device regulation and creating strategies to apply these regulations
• Development of trainings and exchange of knowledge across teams and other departments
• Leader during internal and external audits from the beginning to the end of the process, and making reports of these audits

Requirements

• Bachelor of Life Sciences
• Minimal 2 years of experience within the Medical Device industry
• Minimal 3 years of experience within a strongly regulated environment
• Lead Auditor certification
• Proven experience in building and maintenance of relationships with internal and external authorities
• Excellent knowledge of Medical Device Regulation and standards for the European, Middle Eastern, African and Canadian
market
• Fluency in English and Dutch
• Magnificent organisational and analytical skills
• Excellent team player and communicator

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: 06-02-2019
Country: Belgium
Region: Brussels Hoofdstedelijk Gewest
Employment: Freelance
Expertise: 6 - 10 years
Location Type: On location
Education: Bachelor
Language: English
Sector: Finance
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


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+41 (0)43 508 1743

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+31 (0) 20 658 9804

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SIRE Healthcare

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Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 85 044 4640

SIRE Finance

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Amstelplein 52, 25th floor
1096 BC Amsterdam
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SIRE Engineering

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+31 (0) 10 316 6626

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