Our client is an innovation leader for osteosynthesis implants and is looking for a qualified Regulatory Affairs Consultant to support the Freiburg site immediately. Their high-tech products are developed, manufactured and globally distributed at their headquarters in Switzerland. Remote flexibility is included.

Responsibilities as Regulatory Affairs Consultant:

-Establishment and maintenance of the quality management system according to EN ISO 13485:2016
-Planning and conducting management reviews
-Planning, implementation of internal audits at the site
-Planning, execution and monitoring of external audits, e.g. authorities, notified body, suppliers in accordance with the specifications of the headquarters
-Preparation of regular performance and key figure reports to the QMRA headquarters management

Skills and Experience Required as Regulatory Affairs Consultant:

-Degree in life science, business administration or related
-Very good knowledge of the following standards and norms: ISO 13485, Medical Device Directive 93/42/EEC, Medical Device Directive (EU) 2017/745, Swiss Law on Therapeutic Products, Quality System Requirements (QSR)
-Experience in setting up, implementing and maintaining quality management systems according to EN ISO 13485 in practice
-Experience in technical documentation and document control
-Experience in project management
-Good knowledge of German and English in spoken and written form, other foreign languages an advantage

How to apply

Apply here if you are interested in this opportunity or if you would like a confidential discussion about your career opportunities please reach out to Lisa Gottheil from EPM Scientific.

Disclaimers if necessary: Must have the rights to Work in Germany.