RAQA Associate

This job role supports Regulatory Affairs (RA) and Quality Assurance (QA) functions for medical device and services. They support in preparing and submitting regulatory documents for product registrations, maintaining organized records, and ensuring strict compliance with local industry standards and internal quality requirements. Involves collaborating with global and local team members to gather necessary information, manage quality systems, and assist in addressing regulatory inquiries.

[About ZEISS]

The ZEISS group is a Global Leader in Optical Technology with a 180-year history. The ZEISS Group, headquartered in Oberkochen, Germany, provides innovative solutions in semiconductor technology, industrial quality and research, medical technology and consumer optical technology. The history of the ZEISS group, which began with the founder of Carl Zeiss in 1846 based on the entrepreneurial spirit of “combining theory and practice”, has established itself as a pioneer in the field of optics through ceaseless exploration of the field of optics.

ZEISS Korea has played a key role in the Korean market for the past 40 years. For ZEISS, the Korean Market is One of the Top 5 Global Sales Markets, providing products and services from five business areas to Korean customers:

• Semiconductor Manufacturing Technology

• Industrial Quality Solutions

• Research Microscopy Solutions

• Medical Technology

• Vision Care (Consumer Markets)

[Employement Conditions]

• Division: Medical Technology (의료기기사업부)

• Job Title: RAQA Associate

• Contract: Fixed-term (1yr)

• Location: Seoul

Overview:

Reporting to the SSC Korea RAQA Team Leader, the RAQA Associate is responsible for supporting product registrations (MFDS approvals) and maintaining the Quality Management System (QMS) in accordance with MFDS regulations and internal quality standards. To ensure product compliance and safety, this role assists with regulatory submissions, manages product complaints, and reviews 3PL records, while supporting the inspection and release process to align with global and local business strategies.

Key Responsibilities:

1) Regulatory Affairs (RA) Support

- Assist in the preparation, submission, and maintenance of regulatory documents for product registration and licensing with the MFDS.

- Help monitor changes in local regulations and support efforts to ensure product compliance with evolving MFDS requirements.

- Cooperate with global HQ and cross-functional teams to gather necessary technical data for regulatory submissions.

2) Quality Management System (QMS) Management

- Maintain and update the Quality Management System (QMS) to ensure full compliance with MFDS regulations and internal requirements.

- Prepare and manage Quality Records for product inspection, import, release processes, and 3PL storage environment monitoring through keen cooperation with SCM/3PL.

- Support QMS documentation and KGMP/DGMP certification audits to ensure alignment with HQ and SSC Korea strategies.

- Manage UDI (Unique Device Identification) data provided by HQ/related parties and ensure timely reporting to the authority in accordance with UDI regulations.

- Review product labeling and e-IFU (electronic Instructions for Use) for accuracy and compliance, coordinating closely with 3PL, HQ, and relevant stakeholders.

3) Complaint Handling & Vigilance

- Manage the full lifecycle of product complaints, including initial intake and reporting to appropriate manufacturing sites.

- Lead follow-ups on complaint investigations, coordinate product returns, and ensure timely adverse event reporting to the MFDS.

Qualifications & Requirements:

- Bachelor's degree in Bio-medical Engineering, Life Sciences, or a related field.

- Professional experience in QA within the medical device industry is strongly preferred.

- Good understanding of MFDS regulations and KGMP requirements.

- Effective communication skills in both Korean and English to collaborate with local and global stakeholders.

Your ZEISS Recruiting Team: