Regulatory Affairs Associate II, IVD Submissions

Inbios-International-Inc; Seattle (WA); On-site; USD 91,500 - 125,000; Full time

Benefits offered by this job

Medical, dental, vision, life &  d

401(k) + Roth IRA + FSA options

2 weeks paid vacation + 11 paid holi

Competitive pay and growth

Team-oriented culture

Job summary

InBios International Inc. in Seattle, WA, is seeking a Regulatory Affairs Associate II to join our team.

This full-time, on-site position supports regulatory submissions, lifecycle management, and cross-functional product development for innovative IVD diagnostics. The ideal candidate has 5+ years of FDA-regulated IVD experience (or a PhD with 2+ years), strong regulatory knowledge, and excellent communication.

Qualifications

• Bachelor's or Master's degree in Life Sciences, Bioengineering, Regulatory Affairs, or related field.
• Minimum 5 years regulatory affairs experience in FDA-regulated IVD environment, or PhD with 2+ years experience.
• Excellent knowledge of US and international IVD regulations.
• Strong communication and attention to detail; ability to manage multiple projects.

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 preparation and submission of EUAs, 510(k)s for class II products.
• Support international registrations, create/maintain technical files, and prepare product dossiers.
• Prepare and maintain Design History Files and lead Risk Management.
• Prepare/ review labeling and marketing materials for regulatory compliance.
• Help set regulatory strategy for new product development and stay updated on regulations.

Skills

Regulatory affairs

Communication

Attention to detail

Project management

Statistical analysis

Education

Bachelor's or Master's in Life Sciences

Regulatory Affairs certification (preferred)

Tools

MS Office

SharePoint

Statistical packages

Online research

Job description

InBios International Inc. in Seattle, WA, is seeking a Regulatory Affairs Associate II to join our team.

This full-time, on-site position supports regulatory submissions, lifecycle management, and cross-functional product development for innovative IVD diagnostics. The ideal candidate has 5+ years of FDA-regulated IVD experience (or a PhD with 2+ years), strong regulatory knowledge, and excellent communication.