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A Quality & Regulatory Affairs Specialist in the medical technology industry is responsible for supporting the development, implementation, and maintenance of quality and regulatory processes to ensure compliance with applicable standards and global regulations. This role contributes to the preparation of regulatory submissions , supports internal and external audits and inspections, and helps ensure that medical products meet quality, safety, and performance requirements throughout the product lifecycle. Additionally, the role collaborates on information security and data protection initiatives , promoting cross-functional alignment and continuous improvement across both quality and compliance systems. Key responsibilities Support the implementation, maintenance and improvement of the Quality Management System (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, and EU MDR requirements. Collaborate in the maintenance and improvement of the Information Security Management System (ISMS) in alignment with ISO/IEC 27001, ISO/IEC 27701, and the Spanish National Security Scheme (ENS), ensuring consistency with regulatory and internal requirements. Prepare and submit the regulatory documents and dossiers (e.g., 510(k), Technical Files, CE mark applications). Maintain and control all quality system documentation, ensuring its accuracy, accessibility, and compliance with regulatory requirements. Participate in internal and external audits, as well as inspections, conducted by regulatory authorities or notified bodies. Coordinate and track corrective and preventive actions (CAPAs), non-conformances, and change control activities. Collaborate with cross-functional teams (e.g., R&D, Product, Operations) to ensure quality and regulatory requirements are met during product development and production. Monitor updates to applicable standards and regulations and assist in implementing necessary changes within the organization. Handle customer complaints and elevate high‑risk non‑conformities to the Safety Officer as required. Participate in management reviews, continuous improvement initiatives, and assessments of product and process requirements. Maintain up-to-date regulatory and quality records and contribute to the preparation of reports and metrics. Requirements Bachelor’s degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related technical/scientific field. Minimum of 2 year of experience in a quality or regulatory role within the medical device, medtech, or healthcare industry. Solid understanding of Quality Management Systems and their application in a regulated environment. Familiarity with Information Security Management Systems (ISMS) and data privacy frameworks (e.g., ISO/IEC 27001, ISO/IEC 27701, ENS) is a strong plus. Knowledge of applicable international standards and regulations, including: ISO 13485:2016 EU MDR (Regulation (EU) 2017/745) and legacy Directive 93/42/EEC; FDA 21 CFR Part 820 (Quality System Regulation); Canadian Medical Device Regulations (SOR/98-282). Familiarity with regulatory submission processes, including 510(k), CE Technical Files, and documentation required for compliance. Understanding of design control, validation, verification, and post‑market surveillance processes. Proficiency with QMS software tools, document control systems, and general computer applications. Ability to interpret and apply quality, regulatory and security standards across documentation, process improvements, and product development. Soft skills Strong organizational and documentation skills with a high level of attention to detail. Clear and concise communication, both written and verbal, especially for preparing and reviewing regulatory documents. Structured and methodical thinking, with the ability to manage tasks and priorities in a regulated environment. Initiative and confidence to engage with cross-functional teams and stakeholders to support audits, reviews, and compliance activities. Analytical mindset and problem‑solving skills with a proactive approach to identifying and mitigating risks. Adaptability to evolving regulations, standards, and project priorities. QUALITY COMPLIANCE All Better Care employees are responsible for assuring quality in all they do. The role, including all day‑to‑day tasks and responsibilities, should therefore be executed while adhering to all applicable Quality Management policies, procedures, and requirements to ensure an optimal level of quality in both our products and services. EQUAL OPPORTUNITY EMPLOYER At Better Care, we strive to build a diverse workforce through equal opportunity employment that embraces and leverages the differences each individual has to offer. This job description is only a summary of the typical functions of the job and not intended to be an exhaustive list of all job responsibilities, tasks and duties. #J-18808-Ljbffr
