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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
Döhler Holland BV PamGene International BV Baxter BV (NL) UNIVAR (voorheen Quaron) KLANT Picarro Inc. Instrumentation Laboratory NL (Part of WERFEN) ADD International PharmaFluidics NFZ (Nederlandse Farmaceutische Zorggroep) Lab Services (specialisten in Liquid Handling)(zelfde adres als Merlin Bioproducts) MSD Animal Health Siemens Healthcare Diagnostics Belgie ( Siemens Healthineers) Lamboo Mobile Medical Organ Recovery Systems Launch Diagnostics & Biokit Ltd Carl Zeiss(NL) Micromeritics NV Utrecht Dental amedes Holding AG Fuji Medical Systems Benelux (B) Active Cues - Tovertafel Omron Healthcare NL Eppendorf Nederland BV QPS (Xendo Drug Development) Terumo Europe NV (België)
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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