L251 | Quality And Regulatory Manager

Vitio - Remote Patient Monitoring; Almería; A distancia; EUR 60.000 - 80.000; Jornada completa

Descripción de la vacante

A healthtech startup is seeking a Quality & Regulatory Manager to oversee their quality management system and regulatory compliance. You will be responsible for ensuring conformity with ISO standards and the Medical Device Regulation. The role is remote-friendly and offers the chance to work with cutting-edge technologies. Ideal candidates should have over 5 years of experience in the medical device industry and strong communication skills in English.

Servicios

Flexible work arrangements

Opportunity for skill development

Impact on patient care

Formación

• Minimum 5 years of experience in quality management and regulatory affairs in the medical device industry.
• Extensive experience in regulatory compliance, especially with EU MDR.
• Strong communication skills in English.

Responsabilidades

• Ensure product conformity with Medical Device Regulation and ISO standards.
• Manage compliance with Technical Documentation and Post-Market Surveillance.
• Train staff on regulatory requirements to foster a compliance-oriented culture.

Conocimientos

Regulatory compliance

Quality management

Risk management

Communication skills

Educación

5+ years in medical device industry

ISO 13485 training

Herramientas

ISO standards

QMS software

Descripción del empleo

About Vitio

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 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 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 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 procedural changes.
   • Assume responsibilities as the Person Responsible for Regulatory Compliance (PRRC) under EU MDR, the Technical Responsible Person for AEMPS, and the Management Representative under ISO 13485.
2. Quality Management System (QMS)
   • Build and maintain a robust QMS to ensure full compliance with ISO 13485, tailored to the design, manufacturing, and commercialization of medical devices.
   • Lead the quality function to ensure all manufactured products conform to the QMS before market release.
   • Elevate quality standards through continuous improvement, using feedback and data analysis.
   • Develop and monitor quality metrics to measure QMS effectiveness, product conformity, and customer satisfaction.
   • Advise the CEO and leadership team on quality strategies, regulatory compliance, and continuous improvement.
   • Lead internal and external audits, ensuring readiness for inspections by regulatory authorities and certification bodies.
   • Validate QMS software activities, including planning, risk analysis, and validation reporting.
3. Product Development & Risk Management
   • Coordinate with internal teams to integrate regulatory and quality requirements into product development, manufacturing, QA, and customer service.
   • Facilitate risk management activities throughout the product lifecycle, ensuring alignment with ISO 14971.
4. Training & Culture
   • Educate and train staff on regulatory requirements and changes, fostering a compliance-oriented culture.
5. Information Security Management
   • Ensure the security of information systems in accordance with the Organisation’s Security Policy and Acceptable Use Policy.
   • Complete required training and awareness activities related to information security.

Required Qualifications

• Minimum 5 years of experience in quality management and regulatory affairs within the medical device industry.
• Extensive experience in regulatory compliance, especially with EU MDR.
• Strong verbal and written communication skills in English.
• Proven success in achieving ISO 13485 accreditation and maintaining compliance.
• Training in medical device software, verification, and validation activities.
• Solid background in product release, risk management, and quality assurance in a medical device context.
• Experience in preparing and maintaining Medical Device Technical Documentation.
• Familiarity with global medical device regulations and standards, with specific expertise in software verification and validation, post-market surveillance, and vigilance reporting.

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 your skills.

The original job posting can be found on Kit Empleo: https://www.kitempleo.es/empleo/219454711/l251-quality-and-regulatory-manager-almeria/?utm_source=html