[ Introduction of ZEISS Group & ZEISS Korea ]

The German 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. The Vision Division, which handles advanced optical products for consumers, the Medical Device Division, which is more familiar with Smile LASIK, the Microscope Division, which provides optical and electron microscopes, the Semiconductor Division, which provides semiconductor mask products and services, and the Quality Solutions Division, which measures product quality. is growing by collaborating with Korean customers, companies and research institutes.

Job Title : Regulatory Affairs Specialist

In this role, you will have the opportunity to:

Keep up to date with any changes in regulatory legislation, guidelines, policies and/or industry trends

Prepare, file and get approval of medical device registrations

Conduct Change Impact Assessment, New Product Assessment and any regulatory impact assessment

Communicate with HQ (or manufacturing sites) and regulatory authorities for problem solving and resolution

Execute general regulatory administration duties and compliance requirements as assigned

Ensure compliance with medical device regulations

Quickly report and escalate identified issues to the team as needed

Collaborate with QA to support any quality issues (incl. GMP audit) as required

The essential requirements of the job include:

5-7 years working experience in Medical Device Regulatory Affairs

In-depth knowledge of Medical Device regulations

Excellent verbal and written English

Good interpersonal and communication skill

Preferred:

Working experience in Reimbursement

Experience in global medical device companies

Your ZEISS Recruiting Team:

JinKyoung Song （송진경）, ShinBi Park （박신비）, YuNa Jung （정유나）