Quality and Regulatory Expert (m/f/d)

Responsibilities: Quality Tasks: Manage and maintain the local Quality Management System (QMS) as Local Management Representative. Implement corporate requirements and adapt them to local regulations, creating local instructions as needed. Establish, improve, and monitor quality processes, ensuring regulatory compliance for national business operations. Oversee documentation management, including change management and periodic reviews. Conduct gap analyses, risk assessments, and train staff on QMS procedures and general quality topics. Monitor medical device regulations and implement updates to ensure compliance. Manage complaints, act as Country Complaint Administrator, and oversee supplier quality management (audits, SCAR/SNCR). Support audits by Notified Bodies, Health Authorities, and corporate functions. Handle CAPA/NC processes and prepare management reviews and reports. Assist with technical operations and tender support through workflow tools. Liaise with national authorities (FSCA, recalls) and the RA team. Regulatory Tasks: Register and maintain medical devices and importers with MHRA, ensuring compliance with UK/IE regulations. Handle Certificates of Free Sale and respond to technical/regulatory inquiries. Conduct internal and external audits, ensuring corrective actions are implemented. Update IFUs, packaging, and marketing materials; maintain Pre/Post-Market processes. Support supplier evaluations and stay up to date with evolving regulatory requirements. Act as Local Safety Officer (LSO) for product complaints, trend analysis, and vigilance reporting. Your profile: Bachelor’s degree in Pharmacy, Chemical/Bioengineering, Health Sciences, or a related scientific discipline. Minimum 5 years of professional experience in quality management systems for medical devices or medicinal products in a regulated environment. Strong understanding of Quality Management Systems, ISO 9001/13485, UK/EU MDR/MDD, and Good Distribution Practice (GDP). Proficient in Microsoft Office and relevant QMS software (e.g., QTrack). Excellent communication skills in English, both written and verbal. Detail-oriented, conscientious, and quality-focused with strong organizational skills. Solid regulatory knowledge and ability to work in a structured, compliance-driven environment.

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