Regulatory Affairs Specialist (Medical Devices)

TL;DR

Regulatory Affairs Specialist (Medical Devices): Managing product registrations, license renewals, and KGMP certifications with MFDS and ASEAN authorities with an accent on regulatory compliance and documentation. Focus on coordinating registration strategies, maintaining regulatory databases, and ensuring adherence to local and regional quality requirements.

Location: Onsite in Seoul, South Korea

Company

A company specializing in the manufacturing and importing of medical devices.

What you will do

• Prepare documentation for new product registrations, license updates, and KGMP certifications with MFDS.
• Manage product and establishment registrations with QIA and animal health regulatory authorities.
• Coordinate registration strategies and compliance requirements with ASEAN regional counterparts.
• Maintain regulatory databases and summary reports to track filing and registration trends in the ASEAN region.
• Collaborate with commercial, marketing, and corporate teams to support tender requests and reimbursement queries.
• Provide organizational guidance based on up-to-date domestic and ASEAN regulatory requirements.

Requirements

• Bachelor’s degree or higher in Engineering, Biosciences, Chemistry, or an equivalent field.
• Minimum 2 years of experience in regulatory affairs within medical device manufacturing or importing.
• Working knowledge of MFDS and/or ASEAN region regulations.
• Fluent English proficiency (speaking, writing, and reading).
• Proficiency in MS Office (Word, Excel, Access, Outlook).
• Ability to perform domestic and international business travel as required.

Nice to have

• Experience with patient monitor systems, hospital-based products, or electronic device products.
• Knowledge of FDA/GMP requirements for medical devices.
• Experience with Quality Systems per ISO 13485.
• Experience with animal health product registration processes.

Culture & Benefits

• Professional office-based work environment.
• Opportunity for local and overseas business trips.
• Collaborative team environment that values a "can-do" attitude.
• Structured approach to documentation and record maintenance.