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Regulatory Documentation Specialist
Job Summary
A company is looking for a Regulatory Software Documentation Specialist.
Key Responsibilities
- Develop, reconstruct, and refine Software Requirements Specification (SRS) for compliance with FDA and other regulatory bodies
- Establish and maintain a traceability matrix to align software requirements, risks, and regulatory expectations
- Extract and organize data from various internal sources into a cohesive documentation format
Required Qualifications
- Experience in Medical Device or Clinical Software Documentation within a regulated environment
- Strong understanding of FDA regulatory requirements, ISO 13485, and European regulatory submissions
- Proven experience in writing Software Requirements Specifications (SRS) and traceability matrices
- Familiarity with JIRA, ETQ Reliance, and regulatory submission processes
- Bachelor's degree in Business Administration, Information Systems, or a related field
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COMPLETE JOB DESCRIPTION
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