'Role & Responsibility - Coordinate with various departments to gather necessary data, reviewing and approving Periodic Safety Update Reports (PSURs), Post Market Performance Follow-Up (PMPF), Post Market Clinical Follow-up (PMCF) documents and maintain high standards of quality and regulatory adherence. - Support the submission of assigned post-marketing surveillance reports - Work with our global cross-functional team to revise or establish existing quality system requirements/processes/procedures, procedures, and report templates that comply with new regulations for post-market surveillance reports - Responsibility to understand and maintain awareness of the quality consequences that may arise from the improper performance of their particular work and to perform other duties and projects as assigned. - Ensure the accuracy and completeness of PMS reports, such as periodic Safety Update Reports (PSURs), Post-Market Performance Follow-up (PMPF), Post-Market Clinical Follow-up (PMCF), and Clinical Evaluation Reports (CERs), as well as related reports, as well as maintain appropriate Design History File (DHF) documents, such as risk management files (RMFs). - Raise concerns with management in a timely manner to clarify them, suggest solutions, and lead change as needed. '[자격요건] ㆍ학력: 이공계 학사 졸업 이상 ㆍMS Excel, MS Word 프로그램 사용 가능자 ㆍ관련 분야에서 최소 3년 이상의 경력 또는 기입된 업무를 직접적으로 leading한 경험이 있는 자 [우대사항] ㆍ관련 분야에서 project를 진행하여 성공적으로 완료한 경험이 있는자 ㆍ영어 회화 가능자 ㆍTOEIC 800 이상 An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com