Regulatory Affairs Specialist – IVD Diagnostics (Hybrid)

Regulatory Jobs; Seattle (WA); On-site; USD 92,000 - 125,000; Full time

Benefits offered by this job

Medical, dental, vision, life &dis

401(k) + Roth IRA + FSA

2 weeks paid vacation

11 paid holidays

Competitive pay

Job summary

InBios International Inc. in Seattle, WA is seeking a Regulatory Affairs Associate II to support the development, registration, and lifecycle management of innovative IVD products addressing infectious diseases and biothreats.

The role requires 5+ years of FDA-regulated IVD regulatory experience (or a PhD with 2+ years) and will oversee regulatory submissions, technical files, labeling, and strategy, with on-site work and potential hybrid arrangements after tenure.

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.
• Certification in regulatory affairs preferred.
• Excellent knowledge of US and international IVD regulations.
• Strong written and verbal communication skills.
• High attention to detail.
• Ability to identify compliance risks and elevate 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.

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.

Skills

Regulatory affairs

Project management

Attention to detail

Communication

Education

Bachelor’s or Master’s degree in Life Sciences / Regulatory Affairs

Tools

MS Office

SharePoint

Statistical packages

Online research

Job description

InBios International Inc. in Seattle, WA is seeking a Regulatory Affairs Associate II to support the development, registration, and lifecycle management of innovative IVD products addressing infectious diseases and biothreats.

The role requires 5+ years of FDA-regulated IVD regulatory experience (or a PhD with 2+ years) and will oversee regulatory submissions, technical files, labeling, and strategy, with on-site work and potential hybrid arrangements after tenure.