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.