International Regulatory Affairs manager - F/H

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 activites at bioMérieux?

The Regulatory Affairs Market team is looking for a Regulatory Affairs Manager for supporting all business regions (EME-AFRICA-ASPAC-LATAM-NORAM) in the frame of new RA organization.

The RA Market Dev & Support team composed of 9 people based in France and in United States.

The activities performed by the team are :

• Daily contacts with the local regulatory teams (subsidiaries and distributors) in order to register/renew products .
• Regulatory watch in order to identify requirements and develop the adequate RA strategies
• Answer to question from authorities with support from other departments

Reporting to the RA Market Director, your main responsibilities will be:

• Organizing activity within the team considering Region business priorities. Monitor progress, identify quickly when prioritization required, escalade success and difficulties when relevant
• Provide expertise to the team to assist the activities and during audits/ inspection
• Ensuring that internal tools are updated (activity data capture and RA watch impacts)
• Building strong partnership with subsidiaries, distributors and counterparts
• Set in place/adapt process and tools to ensure that Regulatory activities are performed efficiently by the team. Size opportunity for process improvements
• Develop robust RA watch process in order to adapt regulatory strategies.
• Support transversal project within Regulatory Affairs team

Who are you ?

With a scientific background (master degree) and specialized in regulatory affairs, you have at least 5 years of professional experience in regulatory affairs, either in medical devices or in a "Region" position. You have a previous experience in team management and your leadership is recognized.

You have good communication skills, you know how to interact in an international environment and your English level allows you to influence, challenge and negotiate. Speaking Spanish would be an advantage.

Finally your strong coordination and prioritization capacities along with your solution oriented mindset will be success factors.

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.