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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