• Mainly handle regulatory affairs regarding Cardiovascular product, Orthopedic implant, Neuro-surgery instrument, Power supply medical devices
• Plan, direct, and monitor regulatory affairs activities so that the organisation has the permits, licences, certificates, authorisations, and other approvals it needs to conduct its current and future business activities; and produce, sell, and distribute its goods and services.
• Oversee the most difficult, complex, or large application processes so that the organisation submits a full and accurate application that is likely to be successful.
• Monitor regulatory and industry developments and advise senior management on the potential impact of current and future regulations on the operation of the organisation.
• Establish and maintain positive relationships with government agencies and other regulatory authorities; represent the organisation in matters before regulatory, legislative, or industry standards agencies so that the organisation's interests are advanced.
• Lead, direct, evaluate, and develop a team of regulatory affairs professionals to ensure that the organisation's regulatory affairs activities are conducted accurately, ethically, and according to relevant regulations, laws, and standards.
경력 및 자격요건
• University degree in medical science, medical engineering, biology, chemistry or related field
• Minimum 10 years of experience in Regulatory Affairs (preferably medical device industry)
• Recent GMP/GDP knowledge& experience will be preferred
• Good spoken and written English
기타
- 원서 마감후 1차(서류) 합격자에 한하여 개별연락
- 이력서에 연락처, 희망연봉 게재
- 해외여행에 결격 사유가 없는 자
담당업무
입사지원
돌아가기
02-6281-5015
yhw@nterway.com
