Hays

Regulatory Complaint Handler (m/f/d)

Mannheim | Employment with Hays Professional Solutions GmbH
Reference number
538417/1
Start date
07/21
My duties
  • Assumes full accountability for the management of individual cases (Inquiries, Complaints, PRI/PSIs) for photometric diagnostic tests (drug monitoring, specific proteins) according to regulatory and ISO Quality system requirements and needs of the Country Organizations in a timely manner. 
  • Resolves cases in the assigned area, potentially requiring consultation with more senior team members on technical or process-related aspects 
  • Pro-actively consults / involves a more senior team member in cases not following pre-determined / prescribed process
  • Performs correct processing and documentation for individual cases in the area assigned
  • Cases need to be auditable and well documented to be self-explanatory to a person who has no specialized product or process knowledge (e.g. in an audit).
  • Could represent and communicate result of individual case/issue in interfacing meetings 
  • Could contribute in task forces for individual case/issue in their area of competency.
  • Contributes to creation of “affiliate notifications” (communications to affiliates and ultimately customers via the local organizations) and contributes to creation of reports (any type of trending or KPI reporting, on product performance or process performance) generally used by the team/department to report progress or to be presented to interfacing areas.
  • Permanently optimizes processes to increase quality and efficiency standards with focus on customer, compliance and continuous improvement.
  • Knowledge of regulations and IVD standards, Good Manufacturing Practices (GMP).
My qualifications
  • Graduate Degree (bachelor) from a University of Applied Sciences or from a Professional Education and Training (PET) College (Higher Technical Schools) or equivalent professional experience, e.g. medical engineering, chemistry, biology, biotechnology 
  • Vocational training in technical area completed and several years of work experience, e.g. in a diagnostics laboratory ("MTLA") 
  • Strong communication skills in English (written and spoken) are essential 
  • Knowledge of other languages is a plus  Experience in Salesforce / Aurora (roche internal) 
  • Work experience in the area of medical technology in either 1st or 2nd level support or R&D related functions 
  • Knowledge of the diagnostic market is desired 
  • Knowledge of varied regulatory requirements and quality practices, especially in the area of complaint management (e.g., 21 CFR 820.198, ISO 10002, ISO 9001, ISO 13485)
My benefits
  • A highly motivated team and an open way of communication
  • 30 days leave per year
About Hays
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
My contact at Hays

My contact person
Silke Frauendorfer

Reference number
538417/1

Contact
E-Mail: silke.frauendorfer@hays.de