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Quality and Regulatory Manager (Software as a Medical Device), alacant
Location: alacant, Spain
Job Category: Other
EU work permit required: Yes
Job Reference: 728344989468406579232460
Job Views: 1
Posted: 23.07.2025
Expiry Date: 06.09.2025
Job Description:
Vitio is a startup on a mission to transform healthcare through remote patient monitoring, connecting patients and professionals to improve lives. We’re building human-centered, accessible, and effective technology that truly makes a difference. If you’re looking to create real impact, this is the place.
Role Overview
We are a fast-growing telemedicine startup with a small, agile team of 15 people. As we scale, we are looking for a Quality & Regulatory Manager who can take ownership of our integrated management system and regulatory strategy, while working hands-on to ensure compliance without slowing down innovation.
This is a cross-functional role that requires both strategic vision and operational execution. You will be responsible for maintaining and evolving our quality and information security management systems (ISO 13485, ISO 9001, ISO 27001, ISO 14001), as well as ensuring full regulatory compliance of our medical device software under MDR requirements and IEC 62304 requirements.
You’ll work closely with our product and engineering teams to support the development and release of compliant, secure digital health solutions—including ownership of technical documentation, regulatory processes, and cybersecurity considerations.
We're in a moment full of opportunity, so we're looking for someone proactive, communicative, and resourceful.
Key Responsibilities
* Regulatory Compliance & Strategy: Ensure product conformity with EU MDR 2017/745 and ISO 13485, oversee technical documentation, manage compliance with Post-Market Surveillance, Vigilance Reporting, liaise with regulatory bodies, develop regulatory strategies, and stay updated on industry regulations.
* Quality Management System (QMS): Build and maintain a robust QMS, lead quality assurance processes, develop quality metrics, advise leadership, and lead audits.
* Product Development & Risk Management: Collaborate with teams to integrate regulatory and quality requirements, facilitate risk management aligned with ISO 14971.
* Training & Culture: Educate staff on regulatory requirements, foster a compliance-oriented culture.
* Information Security Management: Ensure information security in accordance with company policies and complete related training.
Required Qualifications
* Minimum 5 years in quality management and regulatory affairs in medical devices.
* Extensive experience with EU MDR.
* Excellent communication skills in English.
* Proven success in ISO 13485 accreditation.
* Training in medical device software, verification, validation, risk management, and technical documentation.
* Knowledge of global medical device regulations, especially software-related activities.
Why Join Vitio?
* Be part of a fast-growing healthtech startup with a real impact on patient care.
* Lead the Quality and Regulatory strategy and implementation.
* Remote-friendly culture with flexible work arrangements.
* Opportunity to work with cutting-edge technologies and develop yourself.
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