Want to see more? Find all job opportunities for both BioFire and bioMérieux worldwide by clicking here.

Description

• Organize, update, and maintain regulatory documentation in accordance with company policy and procedures.
• Assist in audit preparation when needed.
• Support review and maintenance of product labeling.
• Aid in the completion of the following tasks:
• Assist with the preparation of regulatory submissions globally.
• Initiation, collection, and coordination of information for regulatory documents for various purposes.
• Coordination with global/local RA counterparts to obtain product approvals and renewals.
• Conduct research about new regulations and guidance documents.
• Develop and review corporate and department procedures.
• Begin to be able to analyze and understand regulatory requirements and identify solutions; provide possible suggestions for implementation.
• Ensures accurate population of databases for tracking global product registrations.

• Ability to work effectively with multiple disciplines and personalities.
• Self-starter starter, with the ability to work and learn independently.
• Demonstrate initiative and can work both independently and collaboratively in a team structure.
• Strong attention to quality/detail.
• Strong interpersonal and communication skills (written and verbal).
• Ability to handle multiple tasks and priorities.
• Proficient with computer and standard software programs (Microsoft Office, Adobe Pro).
• Excellent organizational, time management, and administrative skills.

BioFire Diagnostics, LLC. is an Equal Opportunity/Affirmative Action Employer. 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 BioFire Diagnostics’ 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).