Technical Manager

About CoMira Diagnostics

CoMira Diagnostics is a Saudi-based medical diagnostics manufacturer focused on localizing advanced PCR technologies.

Position Summary

This is a full-time, on-site role for a Technical Manager based in Riyadh, Saudi Arabia. The Technical Manager will lead and oversee all technical manufacturing at CoMira Diagnostics, ensuring full compliance with Saudi Food & Drug Authority (SFDA) regulations and ISO 13485 requirements.

The role combines technical leadership, manufacturing oversight and regulatory compliance execution, with responsibility for ensuring that production, technical documentation, validation activities, and post-market technical support meet the highest quality and regulatory standards.

Key Responsibilities

Act as the SFDA-designated Technical Manager for the licensed medical device manufacturing facility.

Ensure full compliance with SFDA Medical Device Regulations, ISO 13485, and applicable international standards.

Oversee manufacturing processes, equipment qualification, process validation, and technical controls.

Collaborate closely with the Quality Manager to ensure alignment between technical operations and the Quality Management System.

Lead installation, commissioning, and operational readiness of production equipment.

Support product registration and post-market surveillance activities as required by SFDA.

Provide technical input for supplier qualification, technology transfer, and change management.

Train and supervise technical and production staff.

Mandatory Qualifications

Bachelor's degree or higher in:

Biomedical Engineering

Biotechnology

Medical Laboratory Sciences

Minimum 35 years of experience in medical device manufacturing or diagnostics.

Proven experience working under ISO 13485-certified environments.

Demonstrated knowledge of SFDA regulations for medical device manufacturing.

Strong technical documentation and validation experience.

Fluent in English (Arabic is a strong advantage).

Preferred Experience

Experience with PCR instruments, molecular diagnostics, or IVD products.

Prior involvement in SFDA audits or facility licensing.

Familiarity with technology transfer projects.

Key Competencies

Regulatory compliance mindset

Strong leadership and communication skills

High attention to detail

Ability to work in a start-up manufacturing environment

Cross-functional collaboration capability