CEC Regulatory Affairs Manager

CEC Regulatory Affairs Manager

bioMérieux

Remote, Germany

In this senior role you provide the colleagues in Central Europe Cluster with a high regulatory expertise and with a view on regulatory development and trends.

YOUR JOB

  • Survey, analyze regulations, regulatory guidance and standards; monitor changing regulations, assess impact and provide feedback;
  • Assist in the development of Company RA policies; develop procedures compliant with these policies, regulations, regulatory guidance and standards;
  • Support the regulatory awareness of your colleagues and the implementation of policies and procedures;
  • Develop and validate the local regulatory strategy and ensure consistency at system and global levels; adapt to evolving regulations, technology and products;
  • Assess regulatory compliance of third party products and of their suppliers; assist in due diligence and in the development and review of supply agreements;
  • Influence and negotiate with external stakeholders and regulatory agencies;
  • Be the Person Responsible for Regulatory compliance (PRRC) of the Swiss Authorized Representative, ensuring the tasks defined in given mandates and applicable Swiss and European regulation; manage all activities related to product registration in Switzerland;
  • Mobility: around 15% travel time (external meetings, trainings, etc.).

THIS IS WHAT YOU BRING TO THE JOB

  • In order to be able to perform as Regulatory Affairs Senior Central Europe and PRRC in Switzerland, you need to have a Diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree, Master or equivalent in Life-Science scientific discipline within EU, and at least 3 years of professional experience in Regulatory Affairs or in quality management system related with medical devices/In vitro diagnostic medical devices;
  • Knowledge of QMS requirements (ISO standard knowledge) is a must-have;
  • Experience from an international corporation is a strong plus; you need to be familiar with product profiles, technology and history, with local regulatory agency organizations, rules and key personnel and with professional, trade and standard organizations;
  • You have experience with products and related technical documentation and are used to exchange with local regulatory organizations and with professional, trade and standard organizations;
  • Fluency in German and English language.

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© EuroJobsites 2022

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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