Quality & Regulatory Affairs Manager (m/f/d) for chemicals

10000-1184169365-SGermany

Location: working from home (in Germany)
Reference number: 10000-1184169365-S

PSE is a recruitment agency in Düsseldorf, which provides a portfolio of recruitment services for permanent contracts and temporary jobs to global Japanese companies. We operate across a wide range of sectors and are specialized in matching specialists and executives.

Now our client, an internationally operating chemical company in Düsseldorf, is seeking a

Quality & Regulatory Affairs Manager (m/f/d) for chemicals
*working from home
*freelance contract is possible.

Your responsibilities:

• prepare, coordinate, implement and maintain Quality Management System for clinical lab business
• obtain CE marking in compliance with In Vitro Diagnostic Regulations (IVDR)
• implement QA/QC for reagents and consumables
• accompany projects and technical documentations for medical devices 
• close cooperation with consulting agency, CMO, R&D team
• communicate with nationally and internationally responsible regulatory authorities
• examine conformity and take part in conformity assessment procedures 
• keep up to date with changes in regulatory legislations and guidelines 
• internal contact person regarding technical documentations and the approval of medical devices
• organize staff trainings on topics of regulatory affairs and quality management systems
• communicate and cooperate with clients, manufacturers/scientists and other colleagues

Your profile:

• completed scientific training / studies (e.g. medical technology, biology, chemistry, pharmacy) or a comparable qualification
• more than 5 years of profound working experience in In Vitro Diagnostic Regulations
• working experience in the EU 
• experience in international and external audits
• knowledge about ISO 13485 and ISO 15189
• ability to prepare Quality Management Systems
• ability to prepare technical documentations and obtain CE marking
• business fluent English (written and spoken), further language skills are an asset
• ready to travel particularly to the Netherlands and Switzerland
• work permit in Europe
• analytical thinking, responsible and independent
• excellent communication and negotiation skills across functional, cultural and international boundaries

We offer:

• employee friendly company 
• interesting and challenging tasks in a globally operating company
• fair compensation

Interested?
Please send us your application including your CV (in English), credentials and references (in any language).
We are looking forward to receiving your application. 

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