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Regulatory Manager




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

• 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


Attractive salary and pension package


Mike Odekerken, Recruitment Consultant Medical Devices
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

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