Job Type
Full-time
Description
About the OpportunityWe 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, is experienced in preparing regulatory submissions and supporting cross-functional product development teams and has a thesis-based advanced degree in Life Sciences, Bioengineering, or a related discipline. 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.
About the Position- Position Title: Regulatory Affairs Associate II
- Location: Seattle, WA
- Employment Type: Full-time, exempt | On-site (Hybrid option may be available after employee is established in the position.)
- Salary Range: $92,196 - $125,000 annually
Salary range represents the full pay range for the position and is not the anticipated starting salary range. Individual offers are based on relevant experience, skills, qualifications, position requirements, and internal equity. Employees may progress through the range over time as proficiency and experience in the role develop.
What You'll Do- Represent and/or lead Regulatory Affairs in project teams throughout product life cycle.
- Assist in the development of regulatory strategy for new product development and update strategy as needed, based upon regulatory changes.
- Write and review protocols for analytical and clinical studies in support of regulatory submissions, and train lab personnel who will perform analytical and clinical studies.
- Support clinical study execution, including IRB submissions, site initiation, site management, and ongoing study coordination.
- Lead the preparation and submission of FDA regulatory submissions, such as pre-submissions, EUAs, 510(k) submissions, and De Novo requests for Class II and Class III products.
- Support international registrations, create and maintain technical documentation, and prepare product dossiers in support of maintaining CE mark on current products and obtaining CE mark on new products.
- Prepare and maintain Design History Files.
- Lead Risk Management and Post-Market Surveillance (PMS) efforts.
- Prepare and review labeling and marketing materials to ensure regulatory compliance.
- Keep abreast of the latest regulatory requirements and trends.
- Communicate with the FDA and other regulatory bodies concerning product submissions.
What We're Looking For- Thesis-based Master's degree or Ph.D. in Life Sciences, Bioengineering, or a related discipline.
- 3 - 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.
- Prior experience in US regulatory submissions (pre-submissions, EUA, 510(k), De Novo, PMA) for IVDs is required.
- Direct experience with EU IVDR Notified Body interactions, technical documentation preparation, and PMS reporting is preferred.
- Excellent knowledge of US and international IVD regulations.
- Strong written and verbal communication skills.
- High attention to detail.
- Computer literacy (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.
- Strong interpersonal skills and the ability to collaborate effectively with a variety of personnel within and outside of the company.
- Hands-on experience with lateral flow assays, real-time PCR, and/or ELISAs is preferred.
Work Environment- Office environment with extensive computer-based work.
- Occasional work in a GMP-regulated manufacturing environment and Biosafety Level 2 (BSL-2) laboratory setting.
Perks & 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
Apply TodayJoin a dedicated team committed to advancing diagnostic technologies that improve lives worldwide. Bring your regulatory expertise, collaborative mindset, and passion for quality to help deliver innovative solutions for infectious disease detection and global public health.
