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Senior Regulatory Affairs Specialist

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The company

Our client is a professional Medical Devices organisation, based in Noord-Holland Netherlands. International Medical Devices Company with over 300 products for among others cardiology and orthopedics.

Role description

The Senior Regulatory Affairs Specialist is responsible for preparing global regulatory submissions and communicating regulatory strategies to product development teams. Responsible for development, maintenance, and review of submissions, documentation, labeling, and procedures.

Responsibilities

- Prepare and provide guidance for other employees related to the required documentation and testing for global regulatory submissions and registrations.
- Review and approve labeling and promotional materials to ensure compliance with FDA and international requirements.
- Coordination with cross-functional teams on medical education and training events.
- Review and approve all design control documentation, engineering change requests for design, manufacturing, and labeling changes and custom’s requests to ensure compliance with FDA and international government regulations
- Work with consultants to manage all submissions for a particular country or countries

Requirements

- A Bachelor’s degree; B.S. preferred in engineering, life sciences, or equivalent technical field.
- Several experience in Regulatory Affairs and Medical Devices
- Responsible for ensuring that company submissions are filed in accordance with all appropriate regulations.
- Responsible for ensuring all data and information supplied is both truthful and accurate.
- Responsible for timely filing of domestic and international submissions based on product launch timelines.

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®

Geplaatst door: SIRE Life Sciences®
Geplaatst op: 21-05-2019
Land: The Netherlands
Regio: Noord-Holland
Dienstverband: Permanent
Expertise: 3 - 5 jaar
Locatie Type: Op locatie
Opleiding: Bachelor
Taal: Engels
Sector: Medical Devices
Specialisatie: Research & Development

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Contact

SIRE Life Sciences B.V.

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

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1040 Bruxelles
+32 (0) 2 588 1277

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

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SW1V3PQ London
+44 7307 179882

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ROOOMS Maastricht
Boschstraat 21
6211 AS Maastricht


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