Regulatory Affairs Associate II
About The Position
We are seeking a highly motivated and detail-oriented Regulatory Affairs professional to join our team. This position supports the development, registration, commercialization, and lifecycle management of innovative in vitro diagnostic (IVD) products designed to address emerging infectious diseases and biothreats. The ideal candidate has a strong understanding of U.S. and international regulatory requirements for diagnostic products and is experienced in preparing regulatory submissions and supporting cross-functional product development teams. You are proactive, organized, and capable of managing multiple priorities while working collaboratively with scientific, quality, manufacturing, and commercial teams. If you enjoy solving complex regulatory challenges and helping bring impactful diagnostic solutions to market, we encourage you to apply. This is a regular full-time position that will be supported by project-based funding. The anticipated duration of the funded project is approximately one (1) year. While InBios hopes to retain successful team members beyond the initial project period, continued employment will depend on business needs, project requirements, and the availability of future funding through contract renewals, expanded programs, or new initiatives.
Requirements
- Bachelor's or Master's degree in Life Sciences, Bioengineering, Regulatory Affairs, or a related discipline.
- Minimum of 5 years of regulatory affairs experience within an FDA-regulated IVD manufacturing environment, or a Ph.D. with at least 2 years of applicable industry experience.
- Excellent knowledge of US and international IVD regulations.
- Strong written and verbal communication skills.
- High attention to detail.
- Technical system skills (e.g., MS Office, SharePoint, statistical packages, online research).
- Ability to manage multiple projects and deadlines.
- Strong understanding of statistical analysis.
- Ability to identify compliance risks and escalate when necessary.
- Prior experience in regulatory submissions (pre-submissions, EUA, 510(k), De Novo, PMA) for lateral flow and real-time PCR assays is required.
Nice To Haves
- Certification in regulatory affairs preferred.
Responsibilities
- Represent and/or lead Regulatory Affairs in project teams throughout product life cycle.
- Write/review protocols for analytical studies in support of regulatory submissions.
- Assist in the preparation and submission of EUAs, pre-submissions, 510(k)s for class II products.
- Support international registrations, create and maintain technical files, and prepare product dossiers.
- Prepare and maintain Design History Files.
- Lead Risk Management effort.
- Prepare and review labeling and marketing materials to ensure regulatory compliance.
- Help set the regulatory strategy for new product development.
- Keep abreast with the latest regulatory requirements and trends.
- Communicate with the FDA and other regulatory bodies concerning product submissions.
Benefits
- Medical, dental, vision, life & disability insurance
- 401(k) + Roth IRA + FSA options
- 2 weeks paid vacation + 11 paid holidays (including winter break)
- Competitive pay and growth opportunities
- Supportive, team-oriented culture focused on innovation and impact
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
