Role Description The Regulatory Affairs Associate is responsible for assisting with assembling the regulatory submissions required to market new or modified in vitro diagnostic devices (IVD) in the US and in international markets. This role also helps maintain FDA submission files and records, ex-US technical file documentation, and other documents and policies that support regulatory activities. Key Responsibilities and Essential Functions

• Assists in writing and implementing process improvements for Regulatory Affairs functions
• Maintains and performs regulatory document filing and retrieval in conjunction with SOPs
• Compiles, coordinates, and formats materials required in submissions, license applications, technical file documentation etc.
• Maintains files related to FDA/global regulatory registrations, including communications with FDA/Global regulatory agencies
• Coordinates and formats submissions per FDA and/or other global health authority requirements
• Assists in the creation and implementation of regulatory affairs department policies and procedures to ensure that regulatory compliance is maintained or enhanced
• Support operations by reviewing incoming project contracts and provide guidance for regulatory requirements for projects, as required
• Informs the cross functional team of any new or revised standards, expanded claims, recalls, adverse events, and impact on the IVD product
• All other duties as assigned

Qualifications

• Required: 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
• Preferred: Demonstrates knowledge and understanding of FDA guidelines with proven ability to successfully apply these to work output. Knowledge of FDA and quality systems regulation (QSRs)
• Prior work with IVDs, molecular diagnostics, PCR-based assays, sequencing technologies and/or CLIA laboratories

Requirements

• #LI-Remote

Compensation

• Salary Range: $38.56 - $57.88
• Other compensation elements to include: equity grant, bonus eligible

Benefits

• Adaptive's benefits at-a-glance