[의료기기/임상] Medical Affairs Manager

A global medical device manufacturer is searching for a Medical Affairs Manager. The selected applicant will be leading medical strategy, ensuring compliant scientific activities, and supporting effective product use.

Responsibilities:

• Represent Korea Medical Affairs and collaborate with global, regional, and cross-functional partners, including Clinical, RA/QA, Marketing, Finance, and Supply Chain
• Drive medical affairs strategy, policy and process development, and operational excellence
• Build and manage annual medical plans, budgets, and resource allocation
• Lead people development, including coaching, performance management, and staffing
• Provide medical review to ensure quality and compliance for local and global clinical and pre-market studies
• Review study documents such as protocols, CRFs, and ICFs to ensure compliance with regulations, SOPs, and GCP
• Lead communication with investigators and study sites to monitor progress and resolve issues
• Secure and manage investigators, institutions, documentation, budgets, contracts, and vendors required for clinical studies
• Proactively identify study timelines and risks and implement mitigation plans
• Provide scientific and therapeutic consultation to HCPs based on current clinical evidence
• Plan and deliver HCP scientific engagement programs and safety and clinical use information
• Provide internal medical training, including product knowledge and clinical data updates
• Ensure compliance with regulations, quality policies, and SOPs across all medical activities
• Lead audit responses, CAPA activities, and medical review of ethics and promotional materials
• Strengthen KOL and institutional partnerships and lead advisory boards, symposia, and scientific engagement activities

Requirements:

• Bachelor's degree or above in life sciences or related field
• Fluent level English

Preferred Requirements:

• Advanced degree (Master, PhD) in Medicine (MD, MSc), Biomedical Sciences (MSc/PhD in Biomedical Science), Life Sciences (MSc/PhD in Physiology), Public Health/Epidemiology (MPH, MSc in Epidemiology)
• 15-20 years of experience in Medical Affairs, Clinical Research, or related areas
• More than 3 years of people and team management experience
• Experience in global clinical research, including Korea’s participation in pre-approval trials
• Deep understanding of MedTech or pharma regulations, GCP, clinical trial processes, and data integrity

About the Company:

An international researcher and manufacturer of medical devices, the company aims to improve the lives of clients around the globe. Through careful research, they develop new processes while improving the capabilities of others, lowering risks and raising the bar for global health.

Keywords:

의료 업무, 임상 연구, 의료, 의료 기기, 글로벌

Job Ref: 81XOBU