QA/RA Manager (416493/001) Hamburg, Germany

Quality and Regulatory Affairs Consultant
 
Job type: Permanent
Location: Germany
Salary: Competitive
 
A leading Medical Device company are looking for a Consultant in Quality and Regulatory affairs. They are an international consulting company in the health care sector and offer comprehensive services on quality and project management for medical devices that adhere to the recognised standards of ISO 13485 and 14971. To further strengthen their team, I am looking for applicants who are based across Germany as soon as possible.

Area of responsibilities for the Regulatory Manager
Advising customers on the implementation of projects in medical technology
Technical documentation for the (international) approval of medical devices
Quality management systems for medical device manufacturers
Normative requirements such. B. Risk Management, Clinical Assessment
Able to handle Audits and authority inspections and conducting training
 
Qualifications for Regulatory Manager
Completed (BSc) Science degree
Medical Device experience of at least 2 years- Regulatory or Quality is preferred
Detailed knowledge of regulations such as: Medical Device Directive 93/42 / EEC and Regulation (EU) 2017/745 on medical devices
Knowledge of key standards such as: ISO 13485, ISO 14971 and IEC 62366-1
Ability to moderate workshops and trainings
Fluent in German and English skills (spoken and written)
 
If interested, please reply by email or contact me by phone on +442036178306
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