[헬스케어/품질관리] RAQA Lead

A foreign medical technology company is searching for an RAQA Lead. The chosen applicant will be in charge of obtaining marketing authorisation for company products by liaising with government agencies and notified bodies.

Responsibilities:

• Obtain marketing authorisation for company products by completing regulatory submissions for government agencies and notified bodies
• Identify potential issues that may impact the regulatory strategy and timeline for product registrations
• Review, improve, and maintain processes to meet corporate and latest/prevailing regulatory requirements
• Prepare, submit, and manage facility inspections and audits to obtain necessary approvals
• Establish a local quality management system compliant with Korean regulation
• Contribute to the development and implementation of local regulatory strategies in compliance with Korean regulations
• Responsible for quality management, including QMS management
• Take part as a key auditee during internal and external audits
• Provide guidance on the interpretation and implementation of regulations, guidelines, SOPs

Requirements:

• Bachelor’s degree or above in science, engineering, medical or related (Postgraduate degree, as well as regulatory proficiency based on certifications, is highly preferred)
• More than 8 years of relevant experience working in a combination of QA, RA roles within the medical device or IVDs industry
• In-depth knowledge of the Korean Medical Device Act and relevant regulations
• Excellent communication skills at all levels
• Strong cross-cultural awareness
• Proficient in written and verbal Korean and English

About the Company:

A global medical technology company specialising in diagnostics, medical imaging, and surgical products focused on women's health. The firm is committed to advancing early detection and treatment through cutting-edge technologies in breast health, diagnostic testing, and gynaecological surgery.

Keywords:

Regulatory affairs, quality assurance, engineering, medical device, technology, healthcare,

Job Ref: 7ZQ0P1