RA Specialist

Job Purpose

• Ensure product registration and certification in compliance with Korean regulations.
• Manage regulatory activities required for Korean import requirements and internal procedures.

Key Responsibilities

1. Product Registration & Life Cycle Management

Responsible for registration of new products (IVD instruments, reagents, and medical devices) and change management, including:

• Reviewing and planning submission strategies aligned with corporate, regional, and local objectives.
• Identifying opportunities to accelerate approvals or enable early access during and after product development.
• Confirming regulatory requirements to support local business initiatives.
• Preparing and compiling documentation for new registrations, change registrations, and license renewals.
• Submitting dossiers and managing follow-up communications with Korean health authorities and related agencies.
• Coordinating with internal stakeholders and external partners throughout the registration process.

2. Conformity & Registration of Industrial Application Products

• Reviewing regulatory requirements under the Electrical Appliances and Consumer Products Safety Control Act and the Chemical Substances Control Act to ensure compliance for importation.
• Collaborating with external agencies to obtain KC certification and register reagents in accordance with chemical substance regulations.
• Managing timelines and providing internal updates in a timely and proactive manner.

3. Regulatory Monitoring & Industry Engagement

• Monitoring regulatory changes, assessing business impact, and updating existing registrations accordingly.
• Participating in external regulatory committees to represent industry needs and contribute to improvements in registration procedures.

4. Regulatory Information & Data Management

• Managing regulatory product information and data systems.
• Providing accurate registration information to Sales & Marketing, Supply Chain, and Customer Service teams.

Qualification

• At least 4 year experiences in Regulatory Affairs in IVD and/or medical devices (IVD is favorable)
• Bachelor’s degree in Microbiology, Life Sciences, or a related scientific discipline.
• Regulatory writing skills with the ability to prepare clear, accurate, and compliant documentation.
• Good communication and negotiation skills, with the ability to collaborate effectively across functions and with external stakeholders.
• In-depth knowledge of Korean regulatory requirements and relevant global regulations.
• Proficient in both written and spoken English.