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


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

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

Wir freuen uns über Ihre Bewerbung über unser Bewerbungsformular.