Regulatory Affairs Specialist, IVD Diagnostics (Remote)

Adaptive Biotechnologies; United States; Remote; USD 54,000 - 79,000; Full time

Benefits offered by this job

Equity grant

Bonus eligible

Job summary

Adaptive Biotechnologies in the United States seeks a Regulatory Affairs Associate to support submissions for in vitro diagnostic devices (IVDs) in the US and international markets. You will assist with FDA filings, technical file documentation, and other regulatory materials to help ensure compliant product submissions.

Requirements include a Bachelor’s degree and 2+ years in regulatory affairs; knowledge of FDA guidelines and QSRs is preferred.

Qualifications

• Bachelor’s degree required.
• 2+ years regulatory affairs in the diagnostic or pharmaceutical industry or related field.
• Knowledge of FDA guidelines and quality systems regulation (QSRs) preferred.
• Prior work with IVDs, molecular diagnostics, PCR-based assays, sequencing technologies and/or CLIA laboratories preferred.

Responsibilities

• Assist in writing and implementing process improvements for Regulatory Affairs functions.
• Maintain regulatory document filing and retrieval per SOPs.
• Coordinate and format materials required in submissions, license applications, and technical files.
• Maintain FDA/global regulatory registrations, including communications with agencies.
• Coordinate submissions per FDA/global health authority requirements.
• Assist in creating and implementing regulatory affairs policies and procedures.
• Review project contracts for regulatory requirements as needed.
• Inform cross-functional teams of changes in standards, claims, recalls, adverse events, and impact on IVD products.

Skills

Regulatory affairs

Documentation

Education

Bachelor's degree

Job description

Adaptive Biotechnologies in the United States seeks a Regulatory Affairs Associate to support submissions for in vitro diagnostic devices (IVDs) in the US and international markets. You will assist with FDA filings, technical file documentation, and other regulatory materials to help ensure compliant product submissions.

Requirements include a Bachelor’s degree and 2+ years in regulatory affairs; knowledge of FDA guidelines and QSRs is preferred.