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

Applied Medical -
서울

지금 지원하기

채용공고 세부정보

상세 직무 내용

_________________________________________________________________________________:

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 develop, 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

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검색결과 새로고침

11 지역 채용공고 deployed software engineer, new grad건

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