Regulatory Affairs Specialist

Position Summary

An RA Specialist on the Regulatory Affairs Lifecycle Management (RA LCM) team is responsible for developing regulatory strategies and assessing regulatory risks related to product changes throughout their life cycle. This role focuses on driving post‑market changes (to include design, manufacturing, and labeling updates) through global regulatory approval processes.

Key responsibilities include capturing and communicating worldwide regulatory requirements for product modifications and preparing and submitting change notifications and technical documentation to local RA contacts. The position involves coordination with internal stakeholders, and direct communication with local regulatory contacts worldwide as needed.

Bachelor degree required.

2+ years of experience in regulatory affairs.

• Functional skills including critical thinking, adaptability, time management, communication, problem‑solving, and digital literacy.
• Flexibility, being highly adaptable and resilient to thrive in a dynamic work environment.
• Planning objectives and strategies to achieve them within a set timeline.
• Informing others by sharing clear, timely information to ensure alignment.
• Ability to work cross‑functionally allowing for better collaboration and communication when working across teams to achieve shared objectives.

Bio Merieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant's identity and legal authorization to work in the United States are required of all new hires.

Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in Bio Merieux's or its affiliates' application process by contacting us via telephone at (385) 770‑1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).