1. Act as Designated Representative and Management Representative for both devices and pharmaceuticals; taking and passing of necessary classes and exams to acquire and maintain Certification, as well as meeting the Continuing Education requirements through the continuous review of current and pending laws and regulations.
2. Coordinate, compile, submit, and process regulatory submissions for domestic and international clinical trials evaluation and/or product commercialization.
3. Monitor global regulations and standards to ensure that the company complies with requirements for manufacture and distribution of devices and pharmaceuticals, ensuring compliance with the most stringent applicable laws and regulations.
4. Represent Regulatory Affairs on project teams and providing regulatory guidance regarding: designing, developing, evaluating and commercializing medical devices and pharmaceuticals.
5. Oversee the Complaint Handling, Adverse Event Reporting and Pharmacovigilance system
경력 및 자격요건
1. BS/BA in Pharmacology, Biochemistry, Biology, or related natural science.
2. Possess a minimum of 5-7 years experience in a lead regulatory role at a medical device company.
3. Extensive experience in performing all regulatory functions including the writing and researching information for U.S. submissions and international registrations and reviewing documentation for regulatory compliance.
4. Minimum of 5 years experience in international and U.S. regulatory affairs (U.S. Class II and Class III devices), and EU regulatory affairs (Class IIb and Class III devices), Quality Systems, and/or other medical device manufacturing experience.
5. Hands-on experience with preparation and submission of IDE, 510(k) and original PMAs and PMA supplements and annual reports required.
6. Hands-on experience with preparation of Technical Files and Design Dossier submissions (Class IIb and Class III medical devices) and other international submissions required.
기타
- 원서 마감후 1차(서류) 합격자에 한하여 개별연락
- 이력서에 연락처, 희망연봉 게재
- 해외여행에 결격 사유가 없는 자
담당업무
입사지원
돌아가기
02-6281-5026
jonghak@nterway.com
