▷ 회사: 외국계 의료기 기업

▷ 근무지: 경기

▷ 담당업무
- 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 

- 경력 3년 ~ 10년 

- 이공계 학사 졸업 이상 

- MS Excel, MS Word 프로그램 사용 가능자 

- 관련 분야에서 최소 3년 이상의 경력 또는 기입된 업무를 직접적으로 leading한 경험이 있는 자 

▷ 우대사항 

- 관련 분야에서 project를 진행하여 성공적으로 완료한 경험이 있는자 

- 영어 회화 가능자 

- TOEIC 800 이상 

▷ 상기 job opening에 관심 있으신 분께서는 아래 담당자에게 연락바랍니다. 

- 김종민 이사 (jmkim@hijob.co.kr******@*******.*** / 070-7126-1950)