Are you ready to join aworld leaderin the exciting and dynamic fields of thePharmaceutical and Medical Device industries ?PQE Grouphas been at the forefront of these industriessince 1998, with40 subsidiariesand more than2000 employees in Europe, Asia and the Americas .We are looking for an experiencedQuality Assurance & Regulatory Affairs (QARA) professionalto support a Medical Device organization. In this role, you will act as an extension of the manufacturer's Quality and Regulatory team, helping to maintain compliance with applicable regulatory and quality standards, includingEU MDR 2017/745 ,ISO 13485 ,ISO 9001, andISO 14001 .This is an excellent opportunity for a hands-on quality and regulatory expert who enjoys working in a dynamic MedTech environment and collaborating across multiple stakeholders.Responsibilities include:Maintain and continuously improve the Quality Management System (QMS).Update quality documentation, procedures, forms, and records.Manage non-conformities, CAPAs, deviations, and change controls.Plan, coordinate, and conduct internal audits.Support external audits and inspections, including ISO 13485, ISO 9001, ISO 14001, Competent Authorities, and customers.Follow up on audit findings and corrective actions.Support Management Reviews and quality performance monitoring.Assist with supplier quality management.Support complaint handling, vigilance,



and post-market surveillance.Maintain regulatory documentation for distributed medical devices and support product launches.Support the Technical Responsible Person for Distribution with technical documentation and AEMPS/RECOPS registrations.Requirements:Degree in Life Sciences, Engineering, Pharmacy, Quality, or a related field.Minimum 3 years of experience in Quality Assurance and/or Regulatory Affairs within the medical device industry.Good knowledge of EU MDR 2017/745 and ISO 13485, ISO 9001, and ISO 14001.Experience in QMS maintenance, audits, CAPAs, deviations, change controls, and non-conformity management.Familiarity with complaint handling, vigilance, and post-market surveillance.Willingness to travel.Next StepsUpon receiving your application, if a match is found, the Recruiting Department will contact you for an initial HR interview. If successful, a technical interview with the project stakeholders will be arranged. Following a positive outcome, our recruitment team will discuss the next steps and contractual details.Working at PQE GroupAs a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration, innovation, and professional growth. PQE Group offers the opportunity to work on international projects, develop specialized expertise, and collaborate with industry-leading pharmaceutical companies worldwide.#J-18808-Ljbffr

📌 Quality Assurance & Regulatory Affairs Specialist - Medical Devices (Madrid)
🏢 Pqe Group
📍 Madrid