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Regulatory Affairs Manager

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The company

Our client is a professional Biotechnology and Medical Devices organization, based in Antwerpen Belgium. is a new and upcoming party in the Medical Devices / IVD niche. The company is growing quickly and is expanding its territory by the day.

Role description

My client gives an opportunity to work in a highly innovative, new and growing diagnostics business. This senior level position reports in my client Q&R Director. The function supports regulatory activities for companion and complementary diagnostics in Europe, Middle East and Africa (EMEA).

Responsibilities

• Support the Q&R Leader for regulatory activities for In Vitro Diagnostics (IVD) in development and/or marketed pharmaceutical products. Provide guidance and support to project teams regarding regulatory compliance issues.
• Prepare or review regulatory strategies and plans.
• Create or coordinate STED submission files and design dossiers for EMEA. This might involve managing contractors or interacting with external development parties.
• Interact with notified bodies and regulatory authorities in order to expedite approval of regulatory submissions.
• Manage external standards, including the monitoring of changed/new regulations, guidelines and standards, coordinating the review with the subject matter expert, manage the external standards database.
• Create and submit US State License renewal and extension files. Follow up with the US State health authorities for a smooth continuation of the lab licenses.
• Perform copy review of promotional and scientific material to verify compliance with the approved claims.
• Evaluate regulatory impact of product changes.
• Support the EU Authorized Representative with registration of IVD medical devices and FCA/Recall-letters to Competent Authorities.

Requirements

• Bachelors, preferably Masters, degree in Pharmaceutical, Biomedical Sciences or equivalent with 10 years business experience.
• A minimum of 4-6 years experience with EU conformity assessments and regulatory strategies for In Vitro Diagnostics (IVD Dir 98/79/EC), preferably for molecular diagnostic assays. Experience with 510(k)/PMA (US) or pharmaceutical development process is recommended.
• Working language is Dutch and English; mastering other major European languages is an asset.
• Empathic, dynamic personality with eye for detail.



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SIRE Life Sciences®

Ref. number: 7969
Listed by: SIRE Life Sciences®
Listed on: 20-07-2017
Country: Belgium
Region: Antwerpen
Employment: Permanent
Expertise: 6 - 10 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


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