Consultant Quality Management and Regulatory Affairs Medical Devices, Focus on RA (m/ f/ d)

regular services is a global consulting company for quality management and training for medical device manufacturers and economic players in the medical device industry.

We provide professional advice to companies of different sizes regarding their processes for fast and smooth approval of their medical devices. What sets us apart is our individual support with processes and practical implementation. Our solutions are always tailored to the client’s needs. regular services is based in Munich with branches located in Nuremberg, Pforzheim and Cape Town.

We are looking for a Consultant – Quality Management and Regulatory Affairs Medical Devices, with a focus on QM (m/ f/ d) to start January 1, 2024, but preferably earlier.

 

 

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Field of activity​:

  • Advising clients/ customers on the implementation of regulatory and normative requirements for medical devices
  • Development and implementation of an approval strategy with the client
  • Classification of medical devices considering the intended purpose and marketing area
  • Compiling and editing technical documentation for CE and international approvals
  • Communication with notified bodies and competent authorities for medical device manufacturers
  • Present training courses and seminars for medical device manufacturers and for the cooperation partner TÜV Rheinland Academy

Prerequisites:

  • A degree in medical technology or a degree with a scientific focus or a comparable qualification
  • Professional experience in the field of quality management/regulatory affairs for medical devices
  • You want to develop your skills and expertise in quality management for medical devices with a focus on regulatory affairs
  • You are comfortable with the writing of documents relevant to regulatory affairs
  • Enjoy working with customers and is able to grasp issues very well in conversation in order to develop customer-oriented solutions
  • Experience with country-specific regulatory approval requirements is a plus
  • Ability to work independently, in a goal-oriented and structured manner
  • You are characterized by creativity, organizational talent, the ability to work in a team and very good communication skills
  • Business fluent in German and English

We are looking for candidates for our Munich location, alternatively located in Germany or Austria with the possibility of working from home.

You can expect a permanent position (full-time, part-time also possible) in a dynamic team in which you can work independently and with an entrepreneurial spirit. We offer exciting and varied tasks and attach great importance to work-life balance.

Have we piqued your interest? If so, then send us your complete application documents to: HR@regular-services.com

Munich, January 2024

regular services rs GmbH
Landsberger Straße 155
D-80687 München
Germany
www.regular-services.com