BioFire Diagnostics, LLC. is currently looking for a Regulatory Affairs Associate to join our growing team! The Regulatory Affairs Associate will assist the regulatory affairs team with formatting, assembling, and timely preparation of documents for domestic and international regulatory submissions and ensuring compliance with applicable regulations. The associate will also ensure accurate population of regulatory affairs document databases for tracking global product registrations with most recent and reliable source documents. She/he will be responsible for supporting global regulatory partners to help fulfill regulatory requirements in different countries. May be assigned other regulatory-related duties.
Principal Job Duties and Responsibilities:
Initiate, collect, and coordinate information to prepare regulatory document packages for review and submission to various US government agencies.
Analyze and understand regulatory requirements, assess impact of rule changes and identify solutions; provide directions for proper implementation.
Organize and prepare documents for international submissions. Coordinate with international counterparts to obtain product approvals and renewals.
Conduct research about new regulations and guidance documents, and assist in applying this knowledge to company processes and submission techniques.
Advise on facility requirements for compliance with new/revised regulations.
Support review of labeling and marketing materials.
Review and assess product change impacts (device/labeling) for US and international markets and craft regulatory notification plans.
Assist in the development and review of corporate and department procedures.
Prepare and direct timely preparation of additional information and responses requested by regulatory agencies.
Bachelor's degree in biological sciences.
1 + years of experience in Regulatory Affairs in a medical device or in vitro diagnostic device industry.
Ability to work effectively with multiple disciplines and personalities.
Self-starter, with the ability to work and learn independently.
Demonstrate initiative and have the ability to work both independently and collaboratively in a team structure.
Understanding and familiarity with global regulatory requirements, guidelines, and expectations.
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.
Knowledge of 9CFR regulation a plus.
Internal Number: 1159
About BioFire Diagnostics LLC.
With FDA clearance of the revolutionary FilmArray system, BioFire has set a new standard in molecular diagnostics. Featuring unmatched usability, the FilmArray’s comprehensive respiratory panel tests for 20 viral and bacterial targets in one, 60-minute test. That’s a feat that no other product on the market can match. Physicians attain answers sooner. Laboratories maximize productivity and reduce costs.
Innovation at BioFire continues with the development of new panels like the Blood Culture Identification Panel, Gastrointestinal Panel, Meningitis Panel and the Lower Respiratory Panel. Much like the FDA cleared Respiratory Panel, these new additions will provide fast, comprehensive results.