Expedock
51 - 200 employees
📦 Logistics
🤖 Artificial Intelligence
🚗 Transport
Logistics • Artificial Intelligence • Transport
Expedock is the AI-powered automation service behind some of the leading players in the 7 trillion USD global supply chain. The company is on a mission to build a powerful data infrastructure that drives unprecedented efficiency and profitability across the industry. Expedock focuses on automating the manual processing and inputting of data for freight forwarding and logistics, achieving 99. 99% accuracy. With a team of experts in artificial intelligence and logistics, Expedock aims to transform the future of supply chain and logistics.
Regulatory Affairs Specialist – Medical Devices, IVD
Job not on LinkedIn
🕒 June 11
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Expedock
51 - 200 employees
📦 Logistics
🤖 Artificial Intelligence
🚗 Transport
Logistics • Artificial Intelligence • Transport
Expedock is the AI-powered automation service behind some of the leading players in the 7 trillion USD global supply chain. The company is on a mission to build a powerful data infrastructure that drives unprecedented efficiency and profitability across the industry. Expedock focuses on automating the manual processing and inputting of data for freight forwarding and logistics, achieving 99. 99% accuracy. With a team of experts in artificial intelligence and logistics, Expedock aims to transform the future of supply chain and logistics.
📋 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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