Regulatory Affairs and Quality Assurance (RA/QA) Associate Specialist

As a new generation medical device company, we believe in the power of working together to make a meaningful and positive difference. Applied Medical is committed to improving the accessibility and affordability of high-quality healthcare globally. We achieve this through a vertically integrated business model that enables our team members to develop technologies that enhance clinical care, while offering boundless opportunities for professional growth. We are dedicated to creating an environment where team members of diverse backgrounds are valued, challenged and acknowledged. We are growing our Regulatory Affairs and Quality Assurance (RAQA) teams in Korea in order increase our regional partnerships so we can better serve the evolving needs of the Korean health system.

Position Description

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

• Handle post-market surveillance activities, including complaint handling, adverse event reporting, recalls, and related safety monitoring
• Maintain Quality Management System (QMS) documentation, including the RA/QA master, regulatory databases, material and batch classifications, labeling compliance, and external standards records
• Support product license approvals, including new product registrations, license amendments, renewals, and Korea Good Manufacturing Practice (KGMP) certifications
• Support Korea team to d evelop, implement, and maintain quality system compliance programs and procedures in accordance with Korean local requirements
• Collaborate with Applied Medical headquarters to maintain regulatory and quality compliance with international and local regulations
• Build constructive working relationships across business functions to achieve group and business goals

Success in This Role Looks Like

• Maintaining accurate, audit-ready QMS and regulatory documentation
• Completing product registrations, amendments, and renewals on time and in compliance
• Resolving post-market surveillance activities promptly and accurately
• Applying sound judgment to analyze regulatory issues and generate effective solutions
• Building strong, cooperative relationships across the local team and headquarters
• Seeking and applying feedback to improve regulatory and quality processes

Position Requirements

This position requires the following skills and attributes

• Bachelor's degree or higher in medical device engineering, biotechnology, pharmacy, science, or a related field
• 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)
• Strong understanding of Korean medical device regulations and Ministry of Food and Drug Safety (MFDS) requirements
• Fluent written and spoken English for effective communication with Applied Medical headquarters
• Strong analytical and problem-solving skills
• Ability to work collaboratively across teams and business functions

Preferred

The following skills and attributes are preferred

• Experience with KGMP audits and product license submissions
• NIDS RAC holder
• Continuous learning mindset with a focus on professional development

Benefits

Applied offers benefits package following Korean labor laws

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

• Handle post-market surveillance activities, including complaint handling, adverse event reporting, recalls, and related safety monitoring
• Maintain Quality Management System (QMS) documentation, including the RA/QA master, regulatory databases, material and batch classifications, labeling compliance, and external standards records
• Support product license approvals, including new product registrations, license amendments, renewals, and Korea Good Manufacturing Practice (KGMP) certifications
• Support Korea team to d evelop, implement, and maintain quality system compliance programs and procedures in accordance with Korean local requirements
• Collaborate with Applied Medical headquarters to maintain regulatory and quality compliance with international and local regulations
• Build constructive working relationships across business functions to achieve group and business goals

Success in This Role Looks Like

• Maintaining accurate, audit-ready QMS and regulatory documentation
• Completing product registrations, amendments, and renewals on time and in compliance
• Resolving post-market surveillance activities promptly and accurately
• Applying sound judgment to analyze regulatory issues and generate effective solutions
• Building strong, cooperative relationships across the local team and headquarters
• Seeking and applying feedback to improve regulatory and quality processes

This position requires the following skills and attributes

• Bachelor's degree or higher in medical device engineering, biotechnology, pharmacy, science, or a related field
• 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)
• Strong understanding of Korean medical device regulations and Ministry of Food and Drug Safety (MFDS) requirements
• Fluent written and spoken English for effective communication with Applied Medical headquarters
• Strong analytical and problem-solving skills
• Ability to work collaboratively across teams and business functions