Risk Manager – Medical Devices

November 25

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Ambit Iberia

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We are a company specialized in providing solutions and services related to Information Technology (IT).

201 - 500 employees

Founded 2003

📋 Description

• Support the Risk and DQA team in their activities, including participation in consulting projects. • Work closely with the software engineering team to build strong cross-functional relationships with the other teams involved. • Manage quality assurance for digital projects across functions, ensuring that deadlines, project plans, and quality objectives are met. • Promote organizational compliance with the quality system, including QMS software and the SDLC framework. • Provide quality oversight during risk assessments and for Part 11, Annex 11, and other regulatory compliance activities.

🎯 Requirements

• Strong experience (5+ years) in Quality, including QMS, Design Control, and Risk Management, with experience in development, production, and planning/quality assurance for Software, In Vitro Diagnostics (IVD), or Medical Devices. • Experience setting up and maintaining a Quality Management System (QMS) for software products, aligned with ISO 13485 and ISO 14971. • Risk management experience according to ISO 14971. • Advise, guide, and prepare regulatory documentation for EU commercialization. • Knowledge of MDR (EU) 2017/745 and/or IVDR (EU) 2017/746 regulations. • Fluent in English; Spanish is highly valued. • Design and definition of quality systems according to ISO 13485:2016 and/or 21 CFR 820. • Regulatory knowledge for countries outside the EU and USA (e.g., Canada, Japan, ANVISA), including MDSAP; experience preparing dossiers for facility licensing and US 510(k) submissions. • Preparation of technical dossiers for CE marking.

🏖️ Benefits

• 100% remote • Part-time hours (20 hours/week — ~4 hours/day)