Full-Time Quality & Regulatory Manager

• Management of external audits and communication with competent authority.
• Management of internal audits and communication with relevant departments.
• Maintaining designation under MDR/IVDR and support the development and designation under new schemes.
• Maintaining accreditation under MDSAP, ISO 13485 and UKCA and support the development of other new schemes.
• Coordinate all activities with auditing organisations.
• Coordinate all complaints and regulatory request (CEF) to provide customers and CA appropriate answers.

• Own and oversee all medical devices processes, including the Quality Manual, Non-Conformity and CAPA handling, audits and inspections, document and records control, internal audits, quality management reviews, concessions, and impartiality.
• Supervise the implementation and maintenance of the medical quality management system (QMS).
• Maintain QMS regulatory compliance to support designation and accreditation under MDR/IVDR, ISO 13485, MDSAP, and other relevant schemes.
• Lead internal and external audits and ensure timely closure of CAPAs.
• Conduct the annual Quality Management Review and ensure timely follow-up and closure of actions.
• Manage all regulatory processes to ensure full compliance across all Medical Schemes.
• Plan and implement relevant regulatory training programs in collaboration with training team .
• Manage and develop the Quality & regulatory team, including performance management, coaching, and staff development.

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