Veröffentlicht in: Sonstiges in Deutschland | Verfasst am: |
Quality & Regulatory Affairs Manager (QA/RA)
Germany or Neighbouring Countries (HOME BASED)
Our client is looking for a Quality and Regulatory Affairs Manager for their Clinical Lab Business in Western Europe to be responsible for the establishment and maintenance of Quality Management System (ISO 13485 & ISO 15180).
The key responsibilities will include:
* Obtaining CE marking and ensuring IVD regulations are met
* Responsible for QA/QC
* Preparing and conducting internal, external and supplier audits
* Work closely with consulting agency, CMO and the R&D team
* Work closely with R&D team and implement QC reagents and consumables used for the device
* Work closely with CMO and R&D and support development projects and technical documentation for medical devices
* Review all existing technical documentations
* Communicate with national and international regulatory authorities as well as with notified bodies
* Ensure all documents are compliant with the relevant regulations, rules and standards
* Be the contact point for all departments within the company for all queries relating to technical documentations and approval of medical devices
* Training others on regulatory and quality topics
* Ensure compliance with regulations set by authorities in each country the devices are marketed in
* Liaise with regulatory authorities
* Ensure all quality standards are met and submissions meet deadlines
The ideal candidate will hold a degree or equivalent in a relevant discipline and will have experience in the field of regulatory affairs within the medical device/medical diagnostic industries.
The ability to establish and maintain ISO 13485 and ISO 15189 Quality Management Systems is also essential for this role.
You will also have the ability to prepare all documentation in compliance with IVD regulations, obtain CE marking and conduct all audits (internal, external and supplier).
If you are interested please apply online