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Senior Regulatory Affairs Specialist

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The company

Our client is a professional Medical Devices organisation, based in Utrecht 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®

Listed by: SIRE Life Sciences®
Listed on: 27-05-2019
Country: The Netherlands
Region: Utrecht
Employment: Permanent
Expertise: 3 - 5 years
Location Type: On location
Education: Master
Language: English
Sector: Medical Devices
Specialisation: Medical

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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

Platz 3
6039 Root
Luzern
+41 (0)43 508 1743

SIRE Staffing Solutions

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

SIRE Information Technology

Calypso Building
Kruisplein 480
3012 CC Rotterdam
+31 (0) 10 316 1066

SIRE Healthcare

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Amstelplein 52, 25th floor
1096 BC Amsterdam
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SIRE Finance

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1096 BC Amsterdam
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SIRE Engineering

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SIRE Human Resources

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1096 BC Amsterdam
+31 (0) 85 044 4620

SIRE Staffing

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