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Director Drug Regulatory Affairs

Locatie

Groningen

Bedrijfsprofiel

A high-tech Medical devices company.

Functieomschrijving/taken

The Director Drug Regulatory Affairs will Lead SurgVision’s worldwide regulatory submissions for the Drug specific product lines used in combination with the explorer medical devices as an integrated solution. Align with Program Management functions to support new product development, product launch, product life cycle management and corporate objectives.

Profiel kandidaat

• Bachelor’s degree in Science, Engineering, or equivalent discipline.
• 10+ years medical/drug industry experience.
• Track record in Regulatory Affairs with strong drug submission experienced in the global drug arena.
• Experienced working in (virtual and matrix) teams within a drug regulatory function.
• Experience with quality systems regulations and guidelines, ISO, Etc .
• Knowledge of global adverse event reporting requirements.
• Experienced in submitting biological products, especially antibodies.
• Fluent in English, additional languages are an asset.

Arbeidsvoorwaarden

The salary is competitive and appropriate for the position.

Contactpersonen

If you are interested in this position and would like to know more about it, please contact:

Thema Group Search & Selection
Peter Kremer, Senior Recruitment Consultant / Partner
Tel: +31 6 51 84 61 62
E-mail: kremer@themagroup.nl

Tagcloud Director Drug Regulatory Affairs

RA- Director- Regulatory Affairs–Manager- Medical- devices--Groningen–Medtech –fluorescence- oncology-surgical-GXP- ISO-QMS 502366- CAPA- Quality Management- Breast Cancer-
CQM- Pharma- Farma- Pharmaceutical- Qality Management Systems
The Binding Site Ltd Boma MaxCyte Beta-cell Sanquin Synthon Biopharmaceuticals Covidien - Mallinckrodt Medical Vaxxinova International Hamilton Robotics (NL) Dr. Reddy's (Octoplus) Active Cues - Tovertafel Metrohm Belgium (ionenchromatografie, titratiesystemen, pH meters Immunodiagnostic Systems (IDS) ADD International PamGene International BV Skalar Analytical BV NimaGen B.V part of Biolegio SurgVision Sebia Benelux s.a. Mercachem BV Elementis Specialties Netherlands BV -Delden Bioconnection Novuqare MercachemSyncom A1-Envirosciences
Duitsland

Merowingerplatz 1
40225 DUESSELDORF
E-mail

België

BioVille, Agoralaan
Building A bis
B-3590 DIEPENBEEK
E-mail

Pivot Park Kloosterstraat 9 
5349 AB OSS
E-mail

Nederland

Odiliastraat 92
5401 ZZ UDEN
E-mail

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