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Manager Regulatory Affairs

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The company

Our client is a professional Medical Devices organization, based in Gelderland Netherlands. Manufacturer of Medical Devices.

Role description

- Monitor and ensure that the product portfolio is in line with current regulations in areas where the products are marketed.
- Providing records of the product portfolio in existing and new markets.
- Supporting the internal organization, including product development and marketing on regulatory aspects.
- Supporting the distribution network in the area of ​​regulatory issues.
- implementing incident management.
- Identify problem areas within and / or outside the department, providing solutions for this and implementing improvements in accordance with applicable agreements.

Responsibilities

Manager Regulatory Affairs is responsible for:
- Be aware and stay informed of all relevant regulatory requirements. Actively monitoring developments in the field of regulatory in all relevant markets and advice the management by showing reports and action plans.
- The complete product registration process. This includes coordinating, supervising and organizing registrations, type testing and product tests which are necessary to the admission comply.
- To support and advise on product ranges and market introductions in regulatory aspects. This includes: CE mark, MDD, FDA approval, certifications,
type testing, technical file, etc.
Supporting and advising the subsidiaries and external distributors in regulatory issues.
- The entire incident management process in accordance with established procedure (vigilance). Liaise with the inspection authorities (Competent Authorities) and Notified Bodies.
- Participation in standards committees (NEN / CEN / ISO), trade unions or groups related to the product;
- Coordinating and controlling the activities of the RA department to planned activities according to agreements expire. Conducting appraisal and assessment interviews.
The RA manager is ultimately responsible for the operation of the department as a whole.

Requirements

- You have at least 5 years experience as an RA Manager in an international environment .
- You will have knowledge and understanding of the applicable national and international regulations
- You can set priorities and you are accurate.
- Excellent command of the English language is required.



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SIRE Life Sciences®

Ref. number: 29742
Listed by: SIRE Life Sciences®
Listed on: 20-07-2017
Country: The Netherlands
Region: Gelderland
Employment: Permanent
Expertise: 3 - 5 years
Location Type: On location
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 Maastricht

ROOOMS Maastricht
Boschstraat 21
6211 AS Maastricht


SIRE Group GmbH

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6039 Root
Luzern
+41 (0)43 508 1743

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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 Staffing

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

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