Quality and Regulatory Manager (Software as a Medical Device)
hace 10 horas
A Coruña
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 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) • 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 that all manufactured products conform to the QMS before market release., • Elevate quality standards through a continuous improvement system, using feedback and data analysis to enhance product quality and safety., • 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 to sustain and grow market position., • Benchmark and collaborate with leading organizations to adopt industry best practices in quality management., • Lead internal and external audits, ensuring readiness for inspections by regulatory authorities and certification bodies., • Validation of 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 processes 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 across the organization. 5. Information Security Management • Ensure the security of the information handled and services provided by 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 in regulatory affairs specifically within the medical device industry., • Extensive experience in regulatory compliance, particularly with EU MDR, • Strong verbal and written communication skills in English, • Demonstrated success in achieving ISO 13485 accreditation and maintaining compliance., • Training in medical device software and verification and validation activities., • Solid background in product release, risk management, and quality assurance in a medical device context., • Experience in the preparation and maintenance of Medical Device Technical Documentation., • Familiarity with global medical device regulations and standards, with specific expertise in software verification and validation activities, post-market surveillance and vigilance reporting. Why Join Vitio?
