Regulatory Affairs Associate

This is a fully remote position, open to applicants in United States.

📋 Description

• Support the preparation of regulatory submissions necessary for marketing new or modified in vitro diagnostic devices (IVD) in both US and international markets.

• Manage FDA submission files and records, as well as documentation for technical files outside of the US and other regulatory documents and policies.

• Contribute to the development and implementation of process improvements within the Regulatory Affairs department.

• Ensure proper filing and retrieval of regulatory documents in accordance with Standard Operating Procedures (SOPs).

• Gather, coordinate, and format materials required for submissions, license applications, and technical file documentation.

• Keep files related to FDA/global regulatory registrations updated, including correspondence with FDA and international regulatory bodies.

• Organize and format submissions according to the requirements of the FDA and other global health authorities.

• Assist in the creation and implementation of policies and procedures for regulatory affairs.

• Review incoming project contracts and offer guidance on regulatory obligations.

• Update cross-functional teams on new or revised standards, expanded claims, recalls, adverse events, and their implications for IVD products.

• Carry out any other responsibilities as assigned.

⛳️ Requirements

• Bachelor’s Degree.

• At least 2 years of experience in regulatory affairs within the diagnostic or pharmaceutical industry, or a related degree or certification, or equivalent experience.

• Familiarity with FDA guidelines, with a demonstrated ability to effectively apply these in professional outputs (preferred).

• Understanding of FDA and quality systems regulations (QSRs) (preferred).

• Previous experience with IVDs, molecular diagnostics, PCR-based assays, sequencing technologies, and/or CLIA laboratories (preferred).

• This position does not offer sponsorship for candidates requiring work authorization support.

🏝️ Benefits

• Equity grant.

• Bonus eligible.

• Remote work (Work From Home).