Job Title: Quality and Regulatory Specialist
Location: Seoul, South Korea
About the Company: Our client is a leading innovator in the biotech industry, dedicated to advancing healthcare through cutting-edge research and development. Our client specializes in developing groundbreaking therapies and diagnostic tools that address unmet medical needs. With a strong commitment to quality and regulatory compliance, we strive to deliver safe and effective solutions that improve patient outcomes and enhance the quality of life.
Key Responsibilities:
- Ensure compliance with local and international regulatory requirements.
- Develop, implement, and maintain quality management systems.
- Conduct internal audits and manage external audits.
- Prepare and submit regulatory documents to relevant authorities.
- Monitor and report on quality performance and compliance issues.
- Collaborate with cross-functional teams to address quality and regulatory concerns.
- Stay updated on changes in regulations and standards.
Qualifications:
- Bachelor's degree in a related field (e.g., Quality Management, Regulatory Affairs, Life Sciences).
- Minimum of 3 years of experience in quality assurance and regulatory affairs.
- Strong knowledge of local and international regulations (e.g., ISO, FDA, CE).
- Excellent analytical and problem-solving skills.
- Strong communication and interpersonal skills.
