[Introduction of ZEISS Group & ZEISS Korea]
The ZEISS group is a Global Leader in Optical Technology with a 175-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 36 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:
[Employment Conditions]
Overview:
The Sr. RA Specialist will serve as a leader, responsible for setting the strategic direction and execution of all Regulatory Affairs (RA) activities at ZEISS VISION Korea. This role safeguards compliance with Korean (Medical Devices Act, Digital Medical Products Act, Consumer Chemical Products and Biocides Safety Control Act, etc.) and global ZEISS standards, while shaping robust regulatory systems for the importation and distribution of medical devices, digital medical devices, and industrial goods, etc. As the interface with regulators, global headquarters, and overseas manufacturers, the Sr. RA Specialist will bring technical depth, driving continuous improvement and ensuring ZEISS Korea’s reputation as a trusted partner in the healthcare industry. Along with the healthcare part, this Sr. RA Specialist will also monitor RA/QA topics for ZEISS-related industry areas.
Key Responsibilities:
Execute regulatory strategies for product registrations/renewals/modifications and KGMP certification/renewals with MFDS, NIDS and Notified Bodies. (including Digital Medical Products, Chemicals and Biocides with Government Authorities)
Keep up to date with any changes in regulatory legislation, guidelines, policies and/or industry trends
Prepare and submit regulatory dossiers for product license approval, product license renewal, product license change approval, KGMP certification and KGMP renewal for medical devices, digital medical products, and industrial goods
Conduct product labelling management and regulatory review of promotional materials and advertising safeguard regulatory compliance and reputation
Conduct Product Change Impact Assessment, New Product Assessment and any Regulatory Change Impact Assessment
Communicate with ZEISS VISION global HQ, overseas manufacturers, and regulatory authorities for problem solving and resolution
Execute general regulatory administration duties and compliance requirements as assigned
Ensure compliance with relevant regulations (i.e. Medical Devices Act, Digital Medical Products Act, Consumer Chemical Products and Biocides Safety Control Act, etc.)
Quickly report and escalate identified issues to the team if necessary
Collaborate with QA to support any quality issues if necessary
Qualifications & Experience:
Essential:
10-15 years of RA experience in Medical Device Industry, with a strong background in importer operations
In-depth knowledge of MFDS regulations, ISO 13485, KGMP, and GMP audits
Excellent communication skills in both Korean and English, with ability to liaise with global HQ and overseas manufacturers
Good interpersonal skills
Preferred:
Experience in multinational medical device companies
Strategic mindset with strong problem-solving and risk management skills
Advanced degree in Regulatory Affairs or related fields
Your ZEISS Recruiting Team:
KyuYul Jung （정규열）, ShinBi Park （박신비）