A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For more than 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.

As part of the Regulatory Affairs Team in Marcy l'étoile, we are in search of a DATA-IT Specialist who will act as Regulatory Affairs subject matter expert and support business activities.

What will be your missions ?

• Prepare new product registration dossiers for the DATA-IT franchise (mainly IVD software or SaMD) and submit them to regulatory authorities, as per defined timelines. Coordinate and control regulatory processes to ensure timely execution aligned to product launch and business/registration plan,
• Assist in the development of answers to questions in the interactions/negotiations with regulatory authorities,
• Perform Regulatory Watch to identify new requirements applicable on DATA-IT portfolio and perform related impact assessments,
• Provide feedback on the status of the regulatory submissions and effectiveness of the regulatory processes and contribute to improvement plan,
• Assist in the execution and improvement of regulatory processes and interactions with internal/external stakeholders,
• Participate in audit and inspection readiness activities (such as MDSAP audits, FDA, Internal Audits, ...). Attend inspections and external audits as required,
• Participate to external trade associations (such as Medtech),
• Represent department in transversal company projects that require regulatory input and guidance (such as Cybersecurity, Artificial Intelligence, EHDS, UDI ...).

Who are you ?

• Master's degree or equivalent in Medical Science or Engineering
• Minimum 5 years of experience on regulatory affairs (medical device/IVD industry preferred)
• Excellent verbal and written communication skills
• Fluent communication in English
• Demonstrate success in supporting both growth and product support projects, including complex projects involving ambiguity, in a rapidly changing regulatory and quality environment
• Strong communication skills, both written and verbal, in English and French is required
• Ability to influence peers, higher leaders and external expert or regulatory bodies
• Ability to analyze and use data to drive decisions
• Comprehensive knowledge of regulations applicable to Medical Device/IVD Medical Device. Must be able to interpret regulatory requirements (QSR, IVDR, MDR and local regulations if appropriate)
• Knowledge of preparation of dossiers; technical writing skills to develop clear conclusions based on design documentation and to compile dossiers
• Routine problem solving, develop rationale, and propose solutions
• Mobility: Travel as needed (external meetings with the local and corporate teams, trainings)

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.