Regulatory Affairs Associate

🕒 September 30

🇺🇸 United States – Remote

💵 $38 - $57 / hour

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚔 Compliance

👻 Ghost score 1%

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• Open for 46 days.
• Jobs at this company usually fill in 42 days.

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Adaptive Biotechnologies Corp.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2009

🏥 Healthcare

🧬 Biotechnology

⚕️ Healthcare Insurance

💰 $125M Post-IPO Debt on 2022-09

Healthcare • Biotechnology • Healthcare Insurance

Adaptive Biotechnologies Corp. is a leader in immune-driven medicine, aiming to revolutionize disease detection and treatment. By utilizing the adaptive immune system, the company develops diagnostic and therapeutic solutions powered by its innovative Immune Medicine platform. They offer clinical diagnostics, particularly in Minimal Residual Disease (MRD) testing, and engage in drug discovery and therapeutic development through adaptive immunosequencing technologies. Their biopharma services support the progression of clinical trials and the development of transformative medicines. Adaptive Biotechnologies leverages the complex biology of the immune system, decoding it to advance medical science and improve patient outcomes.

📋 Description

• Assist with assembling regulatory submissions required to market new or modified in vitro diagnostic devices (IVD) in the US and international markets • Maintain FDA submission files and records, ex-US technical file documentation, and other regulatory documents and policies • Assist in writing and implementing process improvements for Regulatory Affairs functions • Maintain and perform regulatory document filing and retrieval in conjunction with SOPs • Compile, coordinate, and format materials required in submissions, license applications, and technical file documentation • Maintain files related to FDA/global regulatory registrations, including communications with FDA/global regulatory agencies • Coordinate and format submissions per FDA and other global health authority requirements • Assist in creating and implementing regulatory affairs policies and procedures • Review incoming project contracts and provide guidance on regulatory requirements • Inform cross-functional teams about new or revised standards, expanded claims, recalls, adverse events, and impacts on IVD products • Perform all other duties as assigned

🎯 Requirements

• Bachelor’s Degree • 2+ years of experience in regulatory affairs in the diagnostic or pharmaceutical industry, regulatory science or related degree or certification, or other related experience • Knowledge and understanding of FDA guidelines with proven ability to successfully apply these to work output (preferred) • Knowledge of FDA and quality systems regulation (QSRs) (preferred) • Prior work with IVDs, molecular diagnostics, PCR-based assays, sequencing technologies and/or CLIA laboratories (preferred) • Not currently sponsoring candidates requiring work authorization support for this position

🏖️ Benefits

• Equity grant • Bonus eligible • Remote work (WFH)

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