QRC Specialist

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

Job Overview

MFDS Product License, Korea GMP Inspection, Post Market requirements, Internal Audit and Compliance to local/ company regulations, maintaining ISO9001, ISO13485 and Getinge QMS requirements.

Duties and Responsibilities

• Ensure that company's product comply with regulatory requirement of South Korea.
• Timely compile materials for license renewals, updates and registrations.
• Preparation of product technical dossier packages for regulatory submissions by working with respective BA QRC team.
• Maintain current knowledge of local regulatory requirements and guidance and standards applicable to company products.
• Provide the regulatory reviews of Adverse Events, FSCA and define the regulatory reportability, report to the authority in timely manner.
• Maintain and comply with ISO 9001, ISO13485 and Getinge QMS requirements.
• Conduct or support internal / external audits and inspections, e.g., ISO 9001, ISO13485, KGMP.
• Maintain and expands relationship with channel partner/ distributors keeping quality requirements as per the quality requirements set up by Getinge.
• Conduct or support distributor audit.
• Comply local labeling requirements.

Requirements

• 3-5 years of experience in Regulatory and Quality Assurance role at medical device company is required.
• The role is to be based in South Korea.
• Proficient in English and Korean language.
• Understand the regulatory requirements for medical devices.
• Ability to work and communicate with others in a professional and effective manner.

About us 

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.