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Regulatory Affairs Assistant

This job posting is no longer active.

Location: Geneve, Switzerland
Position Type: Unfixed Term
Job Function: Administrative Assistance

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World leader in the field of in vitro diagnostics for over 55 years, bioMérieux conceives, develops, produces and markets diagnostics solutions (systems, reagents, software and services) intended for clinical and industrial applications, which determine the origin of a disease or a contamination to improve the health of patients and insure consumer safety.


bioMérieux is present in 43 countries and serves more than 160 countries with the support of a large network of distributors. Its corporate headquarters are located in Marcy l’Etoile, near Lyon, France.


Joining bioMérieux, is choosing to join an innovative company with a long term vision, committed to the service of public health and carried out with a humanistic corporate culture.


Our Group offers numerous possibilities: so come and join the 12,000 bioMérieux employees who already identify with these values!

Regulatory Affairs Assistant

 

What will your responsibilities be within bioMérieux?

 

The primary purpose and overall objective of the position is to ensure the delivery of regulatory activities for Switzerland and to support the Central Europe Cluster in regulatory/quality activities. This position reports to Central Europe Quality Manager.

 

 

Regulatory Affairs Assistant main duties include:

 

  • Responsible for collecting and compiling the regulatory documents required for the registration and/or marketing of distribution products in Switzerland, verifying their completeness and consistency before submittal to the National Authority to obtain/maintain product registration.
  • Maintain database systems for relevant information, pro-actively follow up on activities related to product registration and Economic Operator’s duties, assist in preparing response to regulatory authorities questions within assigned timelines.
  • Manage supporting aspects like registration fees, update of monitoring files, recording progress etc.
  • Support Central Europe Cluster activities related to regulatory and quality as required (e.g. coordination activities, development and review of procedures)
  • Conduct research on regulatory changes and developments and on application requirements and process
  • Advise responsible personnel on regulatory requirements and develop options with recommendations; support regulatory strategy and product launch activities
  • Compliance check of imported products (labels, instructions for use…etc.)
  • Interact with regulatory authorities and execute regulatory processes; provide feedback on application review progress and questions; coordinate and review answers to questions; report on issues.

 

 

 

Who are you?
 

Typical Studies-Experience, Skills and Qualifications:

  • Bachelor of Science Degree in science, Masters’ degree preferred.
  • Experience working with medical devices or In-vitro Diagnostics (IVDs) is desirable.
  • Experience working in Quality or Regulatory Affairs desirable.
  • Excellent IT Skills including an excellent working knowledge of Microsoft office.

 

 

Skills and Qualifications:

  • Attention to details and ability to understand technical and scientific documentation.
  • Multi task and proactive
  • Customer oriented
  • Team spirit
  • Languages skills: French and English must have, German nice to have

Working at bioMérieux means being involved long term with a pioneering, visionary and constantly growing company that allows its employees to live a stimulating and inspiring experience in a fulfilling work environment.

 

Our internal mobility policy offers numerous opportunities for each of our 12 000 employees to blossom throughout their career, while respecting each employee’s individual talents as well as their personal and professional development.
 

At bioMérieux, over 200 professions - both scientific and non-scientific - offer our employees the opportunity to broaden their fields of expertise and develop cross-functional careers. We provide a rewarding experience in an international company that brings together talents from diverse backgrounds, thus fostering a daily aspiration to go beyond the limits.

Helping improve public health around in the world : our mission gives purpose to every profession practiced within the company.

 

bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity/GINA

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