Regulatory Affairs Assistant

Description

At BioFire Diagnostics, LLC. we make the world a healthier place by providing molecular solutions that lessen the time to medical results and empower healthcare professionals to make better diagnostic decisions.

We are proud to be part of the bioMérieux family and the 5,000+ team members across 12 sites and subsidiaries in North America committed to our mission to help save lives around the globe through the power of diagnostics.

Come be a part of our team and our mission as a Regulatory Affairs Assistant!

Job Summary

Entry-level position that gives the opportunity to gain hands-on learning experience about regulations within the medical device industry, assist members of the Regulatory Affairs team by providing organizational and informational support for global regulatory activities, and gain exposure to the development process associated with bringing a new product to market.

Essential Job Duties and Responsibilities

1. Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.
2. Aid more senior regulatory specialists with the following tasks:
   • Initiation, collection, and coordination of information of regulatory documents for various purposes.
   • Preparation and maintenance of product technical files for CE marking.
   • Organization and preparation of documents for international submissions.
   • Coordination with international counterparts to obtain product approvals and renewals.
   • Conduct research about new regulations and guidance documents.
   • Assessment of product change impacts (device/labeling) for US and international markets.
   • Development and review of corporate and department procedures.
   • Adverse event reporting and field actions.
3. Organize, update, and maintain regulatory documentation in accordance with department and company procedures.

Qualifications

Training and Education

Bachelor’s degree or equivalent. May also be actively enrolled in a degree program. Science background is preferred.

Experience

No previous experience required.

Knowledge, Skills and Abilities

• 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.