Technical Responsible Person

HR Bamboos is hiring on behalf of a reputable and growing company in the IVD and medical devices industry. We’re looking for an experienced Technical Responsible Person to oversee the scientific, technical, quality, and regulatory aspects of IVD product operations and ensure compliance with applicable regulatory requirements and international standards.

• Take overall technical and scientific oversight of IVD products throughout their lifecycle, from technical documentation and manufacturing to quality control and post-market activities.
• Own and maintain the Technical File for products and ensure that all relevant documentation remains accurate, complete, and up to date.
• Monitor manufacturing and quality processes to ensure compliance with the company’s ISO 13485 Quality Management System.
• Oversee product risk management in line with ISO 14971, ensuring that product safety and performance risks are properly identified, assessed, and controlled.
• Review and support the management of customer complaints, CAPA, product incidents, and recalls where applicable.
• Act as the company’s official technical liaison with the Medical Equipment and Supplies Administration (IMED) and respond to relevant regulatory requirements and inquiries.
• Ensure regulatory instructions and requirements are effectively communicated and implemented across relevant functions.
• Support regulatory inspections and audits and ensure timely follow-up and closure of identified findings.
• Monitor changes affecting product safety, performance, quality, or regulatory compliance and ensure appropriate change-control processes are followed.

• Doctorate/PhD in Clinical & Anatomical Laboratory Sciences, Medicine (MD), Pharmacy (PharmD), or related Laboratory Sciences fields.
• Minimum 5 years of relevant professional experience in IVD, medical devices, laboratory diagnostics, or a closely related industry
• Proven hands-on experience with Technical Files, ideally with direct responsibility for at least one product from preparation through final approval
• Practical experience implementing or maintaining an ISO 13485 Quality Management System
• Direct experience participating in audits or inspections conducted by IMED or a comparable regulatory authority
• Strong understanding of IVD manufacturing, quality, regulatory, and post-market requirements
• Experience with product risk management and familiarity with ISO 14971
• Experience in handling complaints, CAPA, recalls, and product-related quality issues
• Strong communication and stakeholder management skills, particularly in dealing with regulatory authorities and cross-functional teams

• an approved qualification or ranking under the applicable Technical Responsible Person requirements (MA-WI-15), or readiness to obtain the required qualification