Regulatory Affairs Associate II
About The Position
The Regulatory Affairs Associate II supports the development, registration, commercialization, and lifecycle management of in vitro diagnostic (IVD) products addressing emerging infectious diseases and biothreats. The role works with scientific, quality, manufacturing, and commercial teams to navigate U.S. and international regulatory requirements, prepare submissions, and support product development and clinical studies. The position represents or leads Regulatory Affairs in project teams, develops and updates regulatory strategies, prepares FDA submissions and international registrations, and maintains technical documentation and Design History Files. It also leads Risk Management and Post-Market Surveillance activities, reviews labeling and marketing materials for compliance, and communicates with the FDA and other regulatory bodies. The role is based in Seattle, Washington, and is full-time, exempt, and on-site. A hybrid option may be available after the employee is established in the position. The work is primarily office-based and computer-focused, with occasional work in a GMP-regulated manufacturing environment and a Biosafety Level 2 laboratory.
Requirements
- Master's degree or Ph.D. in Life Sciences, Bioengineering, or a related discipline.
- 3–5 years of regulatory affairs experience in an FDA-regulated IVD manufacturing environment, or a Ph.D. with at least 2 years of applicable industry experience.
- Prior experience with U.S. regulatory submissions for IVDs, including pre-submissions, EUA, 510(k), De Novo, and PMA.
- Excellent knowledge of U.S. and international IVD regulations.
- Strong written and verbal communication skills.
- High attention to detail.
- Computer literacy, including experience with MS Office, SharePoint, statistical packages, and 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 ability to collaborate effectively with personnel within and outside the company.
Nice To Haves
- Direct experience with EU IVDR Notified Body interactions, technical documentation preparation, and PMS reporting.
- Hands-on experience with lateral flow assays, real-time PCR, and/or ELISAs.
Responsibilities
- Represent and/or lead Regulatory Affairs in project teams throughout the product life cycle.
- Assist in developing regulatory strategy for new product development and update strategies based on regulatory changes.
- Write and review protocols for analytical and clinical studies supporting regulatory submissions, and train laboratory personnel performing those studies.
- Support clinical study execution, including IRB submissions, site initiation, site management, and ongoing study coordination.
- Lead preparation and submission of FDA regulatory submissions, including 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 to maintain CE marking on current products and obtain CE marking on new products.
- Prepare and maintain Design History Files.
- Lead Risk Management and Post-Market Surveillance efforts.
- Prepare and review labeling and marketing materials for regulatory compliance.
- Keep abreast of current regulatory requirements and trends.
- Communicate with the FDA and other regulatory bodies concerning product submissions.
Benefits
- Medical, dental, vision, life, and disability insurance.
- 401(k), Roth IRA, and FSA options.
- Two weeks of 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
