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Director Drug Regulatory Affairs

Location

Groningen

Company profile

A high-tech Medical devices company.

Job description/tasks

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.

Candidate profile

• 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.

Terms of employment

The salary is competitive and appropriate for the position.

Contact

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
Dechra Veterinary Products Utrecht Dental Unisensor SA diagnostic engineering Eurofins Global Central Lab (Medinet) MSD Animal Health Eureco Pharma ApotheekZorg Sanquin Interscience België Ge Healthcare ( GE Life Sciences part of Danaher) Hanna Instruments BV Algist Bruggeman ApotheekVoorzorg (Mosadex) Radiometer benelux BV ( Danaher Group) MaxCyte MercachemSyncom LeQuest Asahi Intecc Zwiers regulatory Consultancy Westburg BV(NL) Immunodiagnostic Systems (IDS) Topa Thermal Packaging  BV Mosadex SurgVision
Germany

Merowingerplatz 1
40225  DUESSELDORF
E-mail

Belgium

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

Pivot Park Kloosterstraat 9
5349 AB OSS
E-mail

The Netherlands

Odiliastraat 92
5401 ZZ UDEN
E-mail

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