MDC Associates, Inc.
MDC Associates is seeking an experienced Regulatory Affairs Consultant to provide ad hoc regulatory support on a contract basis, with a focus on FDA IVD regulatory pathways, particularly in Antimicrobial Susceptibility Testing (AST) diagnostics.
Requirements
- Develop, compile, review, and submit FDA premarket submissions
- Prepare and submit FDA Q-Submissions
- Identify appropriate regulatory pathways for new IVDs
- Design analytical and clinical studies
- Act as lead correspondent with FDA throughout the submission and review process
- Create Clinical Study Protocols and Reports
- Assist clients in identifying and contracting with Clinical Trial Sites and/or Reference Laboratories
- Review software and cybersecurity documentation for FDA premarket submissions
Benefits
- Competitive hourly or project-rate compensation
Originally posted on Himalayas
To apply for this job please visit himalayas.app.
Working in United States
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