Regulatory Affairs Specialist – BioMérieux
BioMérieux is hiring a Regulatory Affairs Specialist to support global regulatory submissions, guide product compliance, and help drive innovative IVD solutions through approval pathways. The Life Science Jobs at biomérieux careers are ideal for candidates with regulatory experience who want to work in a fast-paced scientific and medical device environment.
Job Details:
- Position: Regulatory Affairs Specialist
- Department: Scientific / R&D
- Location: United States
- Industry: IVD, Medical Devices, Global Regulatory Affairs
- Experience Required: 2+ years in regulatory affairs
- Employment Type: Full-time
About the Company:
BioMérieux is a global leader in in-vitro diagnostics, delivering innovative solutions since 1963. The company focuses on enhancing public health worldwide through high-quality diagnostic tools, scientific advancements, and a strong commitment to ethical values and global healthcare improvement.
Educational Requirements:
- Bachelor’s degree required
- Science background preferred (life sciences, biology, biomedical fields)
Key Responsibilities of the Regulatory Affairs Specialist Role:
- Develop regulatory strategies and assess regulatory risks
- Support FDA, EU, and global submission preparation
- Maintain regulatory documentation and ensure compliance
- Interpret regulatory guidelines and update internal procedures
- Evaluate change requests for devices and labeling
- Advise project teams on regulatory requirements
- Mentor junior regulatory staff when needed
- Lead regulatory discussions and manage assigned projects
- Track global product registrations accurately
- Perform duties in compliance with company quality standards
Skills Required for the Regulatory Affairs Specialist Role:
- Strong critical thinking, problem-solving, and adaptability
- Excellent communication—written, verbal, and presentation
- Knowledge of IVD/medical device regulations
- Time management and ability to meet deadlines
- Detail-oriented with strong documentation skills
- Ability to work cross-functionally and lead without authority
- Emotional intelligence and professional composure
- Influence and decision-making skills
- Technical aptitude and learning agility
- Ability to manage ambiguity and fast-paced tasks
How to Apply?
Candidates interested for the Life Science Jobs can apply through the company’s official website and stay updated through the biomérieux careers portal alerts for new openings and notifications.
