Regulatory Affairs Associate II
$91,500–$125,000 year
On-siteSeattle, Washington, United States
Job Summary
Represent and lead Regulatory Affairs in project teams throughout the product life cycle, writing and reviewing protocols for analytical studies in support of regulatory submissions. Assist in preparing and submitting EUAs, pre-submissions, and 510(k)s for class II products while supporting international registrations, creating technical files, and maintaining Design History Files. Lead the Risk Management effort, prepare and review labeling materials for compliance, and help set regulatory strategy for new product development. Communicate with the FDA and other regulatory bodies regarding submissions, ensuring adherence to US and international IVD regulations. This full-time role in Seattle, WA, involves occasional GMP manufacturing and BSL-2 laboratory work.
Required Qualifications
- 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
- Prior experience in regulatory submissions (pre-submissions, EUA, 510(k), De Novo, PMA) for lateral flow and real-time PCR assays is required
Desired Qualifications
- Certification in regulatory affairs preferred
- Strong understanding of statistical analysis
- Ability to identify compliance risks and escalate when necessary
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.