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Regulatory Affairs Specialist F/M 1

Location: Marcy l'Etoile, France
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.

 

 

 

What will be your activities at bioMérieux?

 

The Regulatory Affairs Market team is looking for a Regulatory Affairs Officer for EME-AFRICA-ASPAC region in a dynamic regulatory context.

The ASPAC-EMEA- team composed of 7 people is in daily contact with the local regulatory teams (subsidiaries and distributors) in order to guarantee the regulatory compliance of the products (reagents, instruments and software) for EME-AFRICA-ASPAC region.

 

Reporting to the ASPAC-EMEA Manager, your main responsibilities will be:

 

  • Be the privileged point of contact point with subsidiaries and distributors. Coordinate regular follow-ups with the countries (progress of files, new regulations, etc.) and coordination with the Global functions.
  • Responsible of Regulatory activities for a range of products :
    • Contribute to the development of the regulatory strategy
    • Coordinate and prepare the registration and renewal dossier within the defined deadlines in order to send it to the local regulatory contact.
    • Ensure the traceability of these shipments in the regulatory database and ensure reporting.
    • Follow-up of regulatory activities until approvals
  • Responsible for the regulatory watch of a group of countries in order to identify any change having an impact on the product development and/ or leading to new regulatory activities
  • Contribute to different working groups

 

 

What is your profile ?

 

With a scientific background (master degree) and specialized in regulatory affairs, you have at least 3 years of professional experience in regulatory affairs, either in medical devices or in a "Region" position. You have a professional level of spoken and written English. You have high level of organization in your work, are detail oriented with good communication skills. You are also able to change easily your priorities and work on many subjects at the same time.

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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