Role Summary
The Sr. Regulatory Affairs Specialist will own Korea in-country regulatory affairs and quality system activities for LeMaitre's vascular and cardiovascular device portfolio. The role partners closely with the U.S. headquarters on Korea submissions, reimbursement listing, and on-site audits, and serves as the local point of contact for the MFDS. The Sr. Regulatory Affairs Specialist will report to the Korea Country Manager. The role is based at the Korea office, near Suseo Station in Seoul.

Key Responsibilities

• Lead end-to-end registrations of new medical devices (including Class IV and disposable/implantable products) with the MFDS, preparing technical documentation and responding to MFDS review queries
• Oversee license amendments, renewals, and product changes across the in-country product portfolio
• Handle communication with the MFDS throughout the review lifecycle, including EMED workflow
• Drive HIRA health insurance reimbursement listing, in collaboration with the U.S. headquarters and external stakeholders
• Serve as the primary local contact during on-site audits in the U.S.
• Execute post-market surveillance activities, including adverse event reporting, vigilance, and field actions (recalls, CAPA)
• Fulfill duties as the Quality Management Representative (QMR, 품질책임자)
• Collaborate cross-functionally with Sales, Marketing, Clinical, and Supply Chain on regulatory and quality matters

About LeMaitre
LeMaitre is a provider of devices, implants, and services for the treatment of peripheral vascular disease, a condition that affects more than 200 million people worldwide. The Company develops, manufactures, and markets disposable and implantable vascular devices to address the needs of its core customer, the vascular surgeon.

What We Offer

• Direct exposure to global RA/QA operations of a Nasdaq-listed medical device company
• Opportunity to serve as the country lead, working closely with the U.S. HQ and APAC leadership
• Competitive compensation and benefits aligned with the senior specialist level

Required Qualifications

• Bachelor's degree in a scientific or engineering discipline (e.g., life sciences, pharmacy, biomedical engineering, or related field)
• 5 to 8 years of experience in regulatory affairs within the medical device industry
• Demonstrated experience leading registrations of Class III devices; Class IV experience preferred
• Business-level English proficiency with the ability to draft regulatory documents and communicate with U.S. HQ and APAC teams
• No restrictions on overseas business travel, including travel to the U.S.
• Eligibility to be designated as the QMR

Preferred Qualifications

• Class IV or implantable medical device registration experience
• Experience in reimbursement listing
• Experience in vascular surgery, cardiovascular, or other high-risk medical device categories
• Hands-on experience supporting on-site audits conducted overseas
• NIDS RAC