Job Description

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.

Responsible for ensuring that Quality Assurance, Regulatory Affairs and Post Market requirements for Getinge’s Business Area (BAs) are implemented, current and monitored and ensure products supplied meet and are in compliance with the requirements of the local authority.

Job Responsibilities and Essential Duties

• Design implementation, maintenance and certification policies and procedures meet the requirements.
• Ensure that company’s products comply with regulatory requirement of South Korea.
• Keep up to date with regulatory legislation and guidelines.
• Collect and coordinate information and prepare regulatory documentation for submission to regulatory authority.
• Timely compile materials for license renewals, updates and registrations.
• Maintain current knowledge of local regulatory requirements and guidance and standards applicable to company products.
• Develop and write clear explanation for new product licenses and license renewals.
• Provide the regulatory reviews of Adverse Events, FSCA and define the regulatory reportability, report to the authority in timely manner.
• Monitor the FSCA and ensuring completion in due time in coordination with service department.
• Maintaining the QMS in compliance with the ISO standard and applicable quality guidelines issued by global Getinge quality team.
• Conducting Internal & Supplier Audit in compliance with the ISO standards.
• Facing audits by external notified body.
• Perform ad-hoc duties as assigned by the line manager and/or the Company.

Minimum Requirements

• Biomedical engineering, medical pharmacy, electronic engineering, biology, and chemistry majors are preferred
• 5 years’ experience in hands-on QRC experience from Medical Device industry
• RA & ISO 9001&13485 auditor Certifications are preferred.

Required Knowledge, Skills and Abilities

• Extensive knowledge of KGMP, Korean regulations, and experience with preparing submissions
• Experience with QMS in compliance with the ISO9001&13485 standard
• Experience with labeling, inspection and distribution processes and procedures
• Relevant experience working with external parties, such as distributors, est labs, MFDS officials and so on
• Fluent in English

Supervision/Management of Other

• Establishing and monitoring QRC project schedules and strategies

Internal and External Contacts/Relationships

• Main contacts, internal: Local team, Corporate Functions, QRC, Supply Chain, Customer Service, Finance.
• Main contacts, external: Local health authorities, and any other third parties.

Environmental/Safety/Physical Work Conditions

• Ensures environmental awareness and safe work practices are considered and applied in all job-related decisions and activities.
• Uses computer systems, telephone equipment, and other standard office tools and devices to perform assigned duties.
• May work extended hours during peak business periods, such as regulatory submission timelines, audits, or inspections, as required.
• Travel may be required: occasional (on a limited basis for meetings with the Ministry of Food and Drug Safety (MFDS) and for meetings with authorized distributors, both domestically within the Republic of Korea and internationally, as necessary).

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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.  

Getinge is an equal opportunity employer. Getinge will, at all times, will comply with all applicable human rights and other legislation when considering all qualified applicants for employment.