Risk Manager – Medical Devices

This is a fully remote position, open to applicants in Portugal.

📋 Description

• Assist the Risk and DQA team with their initiatives

• Engage in consulting projects as part of the consulting team

• Collaborate closely with the software engineering team to foster an exceptional cross-functional relationship among the various teams involved

• Manage the quality assurance of digital projects in a cross-functional manner, ensuring adherence to deadlines, project plans, and quality goals

• Advocate for organizational compliance with the quality system, utilizing QMS Software and the SDLC framework

• Offer quality oversight during risk assessments, Part 11, Annex 11, and regulatory processes

⛳️ Requirements

• Extensive experience (5+ years) in Quality management, encompassing QMS, Design Control, and Risk Management within the context of development, production, planning, and quality assurance for Software, In Vitro Diagnostics, or Medical Devices

• Proven experience in establishing and maintaining a Quality Management System (QMS) for Software products, compliant with ISO 13485 and ISO 14971

• Proficiency in risk management as per ISO 14971

• Ability to provide advice, guidance, and preparation of regulatory documentation prior to market entry in the EU

• Familiarity with MDR (EU) 2017/745 and/or (EU) IVDR 2017/746 regulations

• Proficient in English

• Spanish language skills are highly regarded

🏝️ Benefits

• Fully remote position

• Flexible working hours