RA (regulatory affairs) 관련 인재 초빙 합니다. (뉴저지) > 구인/구직/과외

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당사는 체외 진단기기 키트 (IVD)로 유명한 중견 기업으로 FDA 관련 인허가 업무를
진행하실 RA Specialist 를 구인 중에 있습니다.

연봉 및 처우: 전 직장 대비 상향 조정 기본
자격:  학사 이상으로  최소 2년 – 8년차 (대리 -과장급)
        신입은 석사 졸업자로 해당 분야 전공자 지원 가능
        OPT 등 비자 스폰서 가능
우대: 생물학과, 의료 공학. 화학과  등 해당 분야 관련 석사 이상 출신자
근무지: 뉴저지주 Cranbury 시
 

관심 있는 분들의 지원 부탁 드립니다.

hr@jobguideusa.com / 전화 문의 : 425-365-9018

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Position Summary

The Regulatory Affairs Specialist compiles and maintains regulatory documentations for submission and registration
of the medical device products. The RA Specialist ensures that all necessary documents are filed and handled
in accordance with international and domestic regulation authorities. This position is responsible for registration of the
 corporate products and requires the ability to multitask and manage multiple deadlines competently.



Duties
• Compile and maintain regulatory documentation databases or systems.
• Gather necessary paperwork and documentation for regulatory filings.
• File submission renewals as needed.
• Keep track of the progress of regulatory submissions, if necessary, once they're submitted to the regulatory agency.
• Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes
• Coordinate, prepare, or review regulatory submissions for domestic or international projects
• Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
• Attend continuing education courses as often as necessary to keep current on changing regulatory policies and procedures
• Prepare or maintain technical files as necessary to obtain and sustain product approval
• Write or update standard operating procedures, work instructions, or policies


Qualification and Experience Requirements
• Knowledge and prior experience in FDA, ISO and applicable regulations and guidelines are required.
• BS/BA in Biology or related field is recommended.
• Knowledge of medical device manufacturing processes is preferred.
• Excellent communication skills and the ability to work well with people at all levels are essential.
• Must have strong organizational, analytical, problem solving, and management skills.
• Experience with MS-Office (especially Excel, Word) is needed.