Regulatory Affairs Associate
Core
Assisting in assembling regulatory submissions for new or modified in vitro diagnostic devices (IVD) in US and international markets.
Role type
Regulatory Affairs Associate
Builds
Regulatory submissions, technical file documentation, and FDA/global registration files
Domain
Healthcare diagnostics / Regulatory Science
Required skills
Regulatory document filing, SOP compliance, submission compilation, FDA/global agency communication, policy implementation, contract review
Preferred skills
FDA guidelines application, Quality Systems Regulations (QSRs), IVD experience, molecular diagnostics, PCR-based assays, sequencing technologies, CLIA laboratory knowledge
Technologies
None stated
Responsibilities
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; 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; Supports operations by reviewing incoming project contracts and providing guidance for regulatory requirements; Informs the cross functional team of any new or revised standards, expanded claims, recalls, adverse events, and impact on the IVD product
Seniority
Mid-level, hands-on IC