Class A, B Medical Device RA(Regulartory Affairs) Specialist(CE, FDA)

주식회사 케어포유
계약형태
정규직
직종
기타
근무형태
대면근무
근무요일
월, 화, 수, 목, 금
근무시간
급여
월급 300 만원
근무지
경기 안양시 동안구 전파로 88
주요 업무
General Accountability Responsible for ensuring compliance with applicable medical device regulations, guidance, and standards for Class A and B POCT devices. - Assist in regulatory submissions, registrations, and listings globally. Key Responsibilities Regulatory Submissions and Compliance: 1. Prepare and compile country-specific regulatory submissions (e.g., 510(k), CE marking, Canadian medical device licenses). 2. Ensure compliance with FDA, EU, and other international regulations. Documentation and Record Keeping: 1. Maintain and update regulatory files, including IDEs, 510(k)s, and CE dossiers. 2. Manage renewals, device listings, site registrations, and annual reports. Communication and Liaison: 1. Interact with regulatory agencies during submission reviews and audits. 2. Coordinate with cross-functional teams (R&D, Quality, Manufacturing) for project registration. Regulatory Intelligence and Updates: 1. Stay informed about changes in regulatory procedures and climate. 2. Communicate updates to management and relevant teams. Complaint Handling and Reporting: 1. Assess device-related incidents for reporting requirements. 2. Compile and submit reportable events to regulatory authorities. Labeling and Promotional Materials Review: Review product labels and promotional materials for regulatory compliance. Audit Support: Provide regulatory input during external audits to minimize non-compliance findings. Project Management: Manage multiple projects with deadlines, ensuring timely completion. Risk Management: Develop and implement risk assessment processes for marketed devices.
자격 요건
Education: Bachelor’s degree in Engineering, Science, or a related scientific discipline. Experience: Minimum of 2 years in regulatory affairs within a medical device or similar organization. Skills: Strong analytical and problem-solving skills. Excellent written and verbal communication skills. Proficient in MS Office applications and databases. Ability to manage multiple projects and deadlines. RAPS certification is preferred.
우대 사항
Experience in applying and obtaining CE or FDA for medical devices.
선호 비자
취업비자(E1~E7)
구직비자(D10)
거주(F2)
영주자격(F5)
국제결혼(F6)
복리 후생
4대보험
출산휴가
연차
인센티브
장기근속 수당
식대제공
생일선물
식사 제공
건강검진
자유복장
관련 이미지
주식회사 케어포유
업종
C.제조업
연락처
01035074368
이메일
jimmy@careforu.co.kr
회사 위치
경기 안양시 동안구 전파로 88 #405-2
·공고 지원은 앱 또는 PC 웹에서 가능해요.
계약형태
정규직
직종
기타
근무형태
대면근무
근무요일
월, 화, 수, 목, 금
근무시간
급여
월급 300 만원
근무지
경기 안양시 동안구 전파로 88