RA & QA Specialist

LVIS Corporation is seeking a Quality Management Specialist to ensure compliance with FDA Quality System Regulations and ISO 13485. The role involves implementing standard approaches to problem solving, reviewing documentation, managing risks, and providing guidance to regulatory agencies. The position is based in Seoul, South Korea and requires collaboration with global partners for regulatory clearance and compliance.

Requirements

• BS or MS degree in Mechanical/Electrical/Industrial Engineering or an equivalent field.
• At least 3+ years of experience working within the Quality organization of a Software Medical Device manufacturer or regulatory affairs within the medical device industry.
• Experience in software lifecycle processes, familiar with software code review and verification methods.
• Knowledgeable in 21 CFR 820 (Quality System Regulations) and ISO 13485 is a must.
• Experience working with strategic suppliers.
• Experience with product lifecycle management (P/N creation, BOM creation, Document Change Control generation and management, Approved Supplier management, etc).
• Quality engineering background and experience inspections, supplier qualifications and audits.
• Strong knowledge of global medical device regulations, standards, and guidelines, including FDA/KFDA regulations e.g. (21 CFR), ISO 13485, and other relevant requirements.
• Proven experience in preparing and submitting regulatory filings (510(k), etc.), and interacting with regulatory agencies.
• Excellent understanding of risk management and quality management systems (ISO 13485, ISO 14971).
• Ability to interpret complex technical and scientific information and translate it into regulatory strategies and documentation.
• Strong project management skills with the ability to prioritize and manage multiple projects simultaneously.
• Excellent communication and interpersonal skills to effectively collaborate with cross-functional teams and external stakeholders.