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CEC Regulatory Affairs Manager

Location: Nurtingen, Germany
Position Type: Unfixed Term
Job Function: Regulatory Affairs

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 45 countries and serve 160 countries with the support of a large distribution network.
Come and join a family-owned global company with a long-term vision, and a human-centered culture.

 

 

 

We have an offer for a position as

 

Regulatory Affairs Senior Central Europe (m/w/d)

Location: Work from anywhere in 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.

 

 

bioMérieux welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

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