仕事の詳細:
The Regulatory Affairs and Quality Assurance (RA/QA) Associate Specialist performs the day-to-day regulatory affairs and quality assurance responsibilities supporting Applied Medical's operations in Korea. This regulatory affairs specialist and quality assurance role keeps post-market surveillance, quality management system documentation, and product license activities compliant with local and international requirements. The RA/QA Associate Specialist collaborates closely with the local RA/QA team, Applied Medical headquarters, and other business functions to maintain regulatory and quality compliance.
Key Responsibilities
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Handle post-market surveillance activities, including complaint handling, adverse event reporting, recalls, and related safety monitoring
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Maintain Quality Management System (QMS) documentation, including the RA/QA master, regulatory databases, material and batch classifications, labeling compliance, and external standards records
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Support product license approvals, including new product registrations, license amendments, renewals, and Korea Good Manufacturing Practice (KGMP) certifications
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Support Korea team to develop, implement, and maintain quality system compliance programs and procedures in accordance with Korean local requirements
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Collaborate with Applied Medical headquarters to maintain regulatory and quality compliance with international and local regulations
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Build constructive working relationships across business functions to achieve group and business goals
Success in This Role Looks Like
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Maintaining accurate, audit-ready QMS and regulatory documentation
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Completing product registrations, amendments, and renewals on time and in compliance
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Resolving post-market surveillance activities promptly and accurately
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Applying sound judgment to analyze regulatory issues and generate effective solutions
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Building strong, cooperative relationships across the local team and headquarters
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Seeking and applying feedback to improve regulatory and quality processes
職種要件:
This position requires the following skills and attributes:
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Bachelor's degree or higher in medical device engineering, biotechnology, pharmacy, science, or a related field
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One to three years of experience in regulatory affairs and quality assurance within the medical device industry (Fresh graduates with relevant internship experience may be considered)
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Strong understanding of Korean medical device regulations and Ministry of Food and Drug Safety (MFDS) requirements
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Fluent written and spoken English for effective communication with Applied Medical headquarters
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Strong analytical and problem-solving skills
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Ability to work collaboratively across teams and business functions
希望:
The following skills and attributes are preferred:
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Experience with KGMP audits and product license submissions
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NIDS RAC holder
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Continuous learning mindset with a focus on professional development
利点:
Applied offers benefits package following Korean labor laws
