Regulatory Affairs Associate II - IVD FDA Submissions

Inbios-International-Inc; Seattle (WA); On-site; USD 92,000 - 125,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

401(k) + Roth IRA + FSA

Job summary

InBios International Inc. in Seattle, WA seeks a Regulatory Affairs Associate II to oversee regulatory activities for FDA-regulated IVD products.

You will support product lifecycle, prepare regulatory submissions, and collaborate with cross-functional teams to navigate evolving requirements. The role requires a thesis-based MS or PhD in Life Sciences or related field, 3–5 years of regulatory experience (or PhD with 2+ years), and strong communication skills.

Qualifications

• Thesis-based master's degree or Ph.D. in Life Sciences, Bioengineering, or related discipline.
• 3–5 years of regulatory affairs experience in FDA-regulated IVD environment, or Ph.D. with at least 2 years of applicable industry experience.
• Experience in US regulatory submissions (pre-submissions, EUA, 510(k), De Novo, PMA) for IVDs.
• Notified Body interactions, technical docs, and PMS reporting in EU IVDR preferred.
• Excellent knowledge of US and international IVD regulations.
• Strong written and verbal communication skills.
• Computer literacy (MS Office, SharePoint, statistical packages, online research).
• Ability to manage multiple projects and deadlines.
• Strong understanding of statistical analysis.
• Identify compliance risks and elevate when necessary.
• Collaborative with diverse teams.
• Hands-on experience with lateral flow assays, RT-PCR, and/or ELISAs preferred.

Responsibilities

• Represent or lead Regulatory Affairs in project teams across the product lifecycle.
• Develop regulatory strategy for new product development and update as needed.
• Write and review study protocols and train lab personnel for analyses.
• Support clinical study execution, including IRB submissions and site management.
• Lead FDA submissions (pre-submissions, EUA, 510(k), De Novo) for Class II/III products.
• Support international registrations and maintain CE marks.
• Prepare and maintain Design History Files.
• Lead Risk Management and Post-Market Surveillance efforts.
• Prepare and review labeling and marketing materials for compliance.
• Stay updated on latest regulatory requirements and trends.
• Communicate with FDA and other regulators about submissions.

Skills

Regulatory affairs

Communication skills

Multitasking

Statistical analysis

Interpersonal skills

Lab assay experience

Lateral flow assays

Education

Thesis-based MS or PhD

Tools

MS Office

SharePoint

Statistical software

Job description

InBios International Inc. in Seattle, WA seeks a Regulatory Affairs Associate II to oversee regulatory activities for FDA-regulated IVD products.

You will support product lifecycle, prepare regulatory submissions, and collaborate with cross-functional teams to navigate evolving requirements. The role requires a thesis-based MS or PhD in Life Sciences or related field, 3–5 years of regulatory experience (or PhD with 2+ years), and strong communication skills.