Expedock
51 - 200 employees
Expedock is the AI-powered automation service behind some of the leading players in the 7 trillion USD global supply chain. We are on a mission to build the powerful data infrastructure that will drive unprecedented efficiency and profitability to all players in the industry.
Regulatory Affairs Specialist – Medical Devices, IVD
Job not on LinkedIn
🔥 8 minutes ago
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Expedock
51 - 200 employees
Expedock is the AI-powered automation service behind some of the leading players in the 7 trillion USD global supply chain. We are on a mission to build the powerful data infrastructure that will drive unprecedented efficiency and profitability to all players in the industry.
📋 Description
• Author Submissions & Technical Files: Draft and compile technical documentation for EU MDR (Annex II/III), UKCA, and FDA 510(k) submissions • Maintain QMS Compliance: Support and manage ISO 13485-compliant Quality Management Systems • Conduct Gap Analyses: Perform regulatory gap assessments against relevant regulations • Manage Risk & Clinical Data: Prepare risk documentation and draft/review Clinical and Performance Evaluation Reports • Drive Post-Market Activities: Support PMS activities and vigilance monitoring • Handle Agency Queries: Draft responses to regulatory inquiries • Ensure Audit Readiness: Maintain organized regulatory files and submission trackers • Monitor Intelligence: Track evolving regulatory requirements
🎯 Requirements
• At least 2 years of hands-on QA/RA experience strictly within the medical device or IVD industry • A background in biomedical engineering, life sciences, or a related technical discipline is highly valued • Strong working knowledge of ISO 13485, ISO 14971, and at least one major regulatory market (EU MDR 2017/745, UKCA, or US FDA 510(k)/Part 820) • Experience independently leading full submissions end-to-end or successfully resolving Notified Body/regulator queries is a major plus • Exposure to specialized standards like IEC 62304 (software), IVD requirements, or EUDAMED, alongside familiarity with eQMS platforms (e.g., Qualio, Greenlight Guru, MasterControl) • RAPS RAC certification is a plus • Flawless written English tailored for regulator-facing documents • Self-starter who thrives in a remote environment
🏖️ Benefits
• Remote work • Work from home option
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