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Regulatory Manager

Locatie

Amsterdam

Functieomschrijving/taken

The regulatory manager will be responsible for obtaining, renewing and documentation of regulatory certifications of Asahi Intecc’s products (medical devices) within Asahi Intecc Europe’s territory, mainly Europe, CIS, Turkey and Israel. This include, but not limited to the following:
• Preparation of necessary documents for the application for CE mark, and other local regulatory certifications
• Correspondence with the notifying body (DEKRA, etc)
• Management of regulatory application and renewal schedule based on the product’s launching schedule
• Checking distributorship/agent contracts to make sure only certified products are included in the contract
• Creating and maintaining regulatory-related master file for the ERP system (SAP), making sure only certified products are shipped
• Creating and maintaining a concise regulatory-related database, keeping track of certifications status of the products (per country, validity, etc)
• Active research on updates/changes on regulations and providing prompt feedback to the regulatory department at the headquarters

Profiel kandidaat

Requirements
• At least 5 years of experience in the regulatory for medical device sector, with excellent understanding of CE application process
• Outstanding communication
• Good command of English, both verbally and written
• Knowledge of Japanese language will be appreciated
• Well-organized and can manage schedule, delivering projects and assignments on time
• Has high standards of work ethics and the ability to maintain professional relationship with peers, supervisors and subordinates
• Ability to work with Microsoft Office (Word, Excel, Outlook, PowerPoint, etc.)
• Holds HBO/WO (Bachelor/Master) diploma or equivalent

Arbeidsvoorwaarden

Attractive salary and pension package

Contactpersonen

Mike Odekerken, Recruitment Consultant Medical Devices
E: odekerken@themagroup.nl
T: +31 6 15 686 949

Tagcloud Regulatory Manager

medical devices - minimal invasive - Cardiology - Neurology - Radiology - catheter - guide wire - Regulatory Affairs - Certification - ISO 13485 - Japanese

Biomedic BV (now Part Medical) Fuji Medical Systems Benelux (B) Carl Zeiss(NL) Bio-Works Technologies AB Canon Nederland Corbion Purac (KLANT) DuPont Industrial Biosciences Boma Allergan BV ( merged with Actavis) Liconic Westburg BV(NL) Eppendorf Nederland BV LUMINEX AVEBE Group Veendam (=KLANT) Konica Minolta Medical & Graphic Imaging Europe BV (Nederland) Mosadex Omron Healthcare NL Innogenetics (now: FUJIREBIO) Molecular Devices (B) (Danaher Group) Radiometer benelux BV ( Danaher Group) ApotheekVoorzorg (Mosadex) Panasonic Biomedical Sales Europe (PHCBEU) formerly Sanyo Gallenkamp Vaxxinova International amedes Holding AG Forcare
Duitsland

Merowingerplatz 1
40225 DUESSELDORF
E-mail

België

BioVille, Agoralaan
Building A bis
B-3590 DIEPENBEEK
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Pivot Park Kloosterstraat 9 
5349 AB OSS
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Nederland

Odiliastraat 92
5401 ZZ UDEN
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