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!
Regulatory Affairs Assistant will assist the Regulatory Affairs team by providing organizational and informational support for product registration in China, while acquiring hands-on learning experience with regulations governing the medical device industry. The Regulatory Affairs Assistant will gain exposure to the development process associated with registering new IVD products in China.
Essential Job Duties and Responsibilities
- Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.
- Support product registration in China by working cross-functionally and collecting information from various departments.
- Coordinate and respond to requests from NMPA.
- Assist with change assessments and regulatory notifications.
- Process notarization & legalization of registration documents.
- Maintain and organize registration document spreadsheets.
- Participate in the review of new NMPA regulations and guidance documents.
- Assist with follow-up and data management for post market surveillance activities.
- Performs other duties as assigned.
- Must be a U.S. citizen or permanent resident.
Training and Education
- Bachelor’s degree in scientific field or equivalent
- Previous lab and/or medical device experience a plus but not required
Knowledge, Skills and Abilities
- Advanced written and verbal Mandarin language proficiency required
- Excellent written and verbal communication skills
- Ability to work cross-functionally and collect information from various departments (e.g., R&D, Clinical, QA, Engineering, Software, etc.) to support product registration in China
- Hands-on, action-oriented, continuous improvement minded
- Willingness to work with changing priorities with enthusiasm
- Self-starter, with the ability to work and learn independently
- Proficient in Microsoft Office Suite and Adobe Acrobat
- Strong attention to quality/detail
- Excellent organizational, time management, and administrative skills
- Physical requirements found in a general office setting