Quality And Regulatory Manager (Software As A Medical Device)

Quality and Regulatory Manager (Software as a Medical Device) Quality and Regulatory Manager (Software as a Medical Device)

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

1. Regulatory Compliance & Strategy

• Ensure product conformity with the Medical Device Regulation (EU MDR 2017 / 745) and the Quality Management System (ISO 13485), focusing on compliance throughout the product lifecycle.
• Oversee the conformity of Technical Documentation and the EU Declaration of Conformity, ensuring all documentation meets regulatory requirements.
• Manage compliance with Post-Market Surveillance (PMS) obligations, including the monitoring, evaluation, and reporting of post-market activities.
• Fulfill Vigilance Reporting obligations, ensuring timely reporting of adverse events, corrective actions and significant changes to regulatory bodies.
• Liaise with regulatory bodies, acting as the primary point of contact for all regulatory communications, submissions, and inquiries.
• Develop and implement regulatory strategies to facilitate market entry for new products and maintain compliance for existing products.
• Maintain up-to-date knowledge of industry regulations (EU MDR, FDA, MDCG guidelines etc.), analyzing updates and implementing necessary changes in procedures and compliance strategies.
• Assume responsibilities as the Person Responsible for Regulatory Compliance (PRRC) under EU MDR, the Technical Responsible Person (Responsable Técnico) for AEMPS, and the Management Representative under ISO 13485.

2. Quality Management System (QMS)

4. Training & Culture

5. Information Security Management

Required Qualifications

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.

Seniority level

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