CDI - Product Regulatory Affairs Specialist - F/M

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For 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 are your missions?

In the CARAT department (Clinical Affairs and Regulatory Affairs Team), in the Regulatory Affairs Product team, you will define, develop and implement regulatory strategies for the successful and fast worldwide registration of IVDs in a flex position for the Clinical Microbiology and Immunology units. The job responsibility includes, overseeing regulatory approvals for Europe (CE Marking with our notified body), the US (FDA), and China (NMPA).

Lastly, you will ensure that relevant corporate regulatory processes are established, continuously improved and followed.

Main Accountabilities:

• Ensure timely execution of regulatory submissions in line with company strategies,
• Provide expertise in translating regulatory requirements into practical, workable plans,
• Validate product labels, instructions for use, advertising and/or promotional materials,
• Assist in drafting and validating answers to questions from regulatory authorities; monitor progress and escalate delays, problems as necessary
• Develop and implement regulatory operating guidelines/SOPs and common work practices/strategies within the team, supported by an efficient regulatory watch,
• Understand, investigate regulatory history of similar products in order to assess regulatory implications for new products

What is your profile?

• Strong scientific background (e.g. Bachelor, or Master’s Degree),
• Knowledge and understanding of regulatory processes with minimum 2 years of practice in the field of IVD’s/MDs in an international environment,
• Good understanding of QMS requirements (design and change control processes), as well as of audits/inspections.

Soft skills:

• Ability to work in an international environment,
• Strategic and analytical thinker, problem solver, and planner with excellent organizational skills,
• Capacity to influence, challenge and negotiate,
• Clear communication to internal/external stakeholders.

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.