Home Job Postings Regulatory Affairs Associate Position This topic has replies, 0 voices, and was last updated 3 years ago by Jennie Kang. Now Editing “Regulatory Affairs Associate Position” Name * Password * Email Topic Title (Maximum Length 80) Company * Location Expires at 저희 SigmaGraft는 플러튼에 위치한 메디칼 제품 제조 회사이며 아래와 같이 직원을 모집합니다. (홈페이지: http://www.sigmagraft.com) Regulatory Affairs Associate Position Job Summary To provide knowledge and experience with creating/revising Design History Files, CE files, update internal procedures and other documents for changes in both FDA and EU regulations, and work with other departments for validation activities to meet regulatory requirements. Key Responsibilities • Provides guidance on regulatory requirements necessary for strategic and contingency planning, including developing regulatory strategic plans to R&D and Quality Departments for solutions. • Register new products by working with regulatory agencies and notified bodies for product commercialization • Work with R&D to prepare DHF, CE, and Risk Management Files • Conduct literature reviews for CER files and for Post Market Surveillance • Create/revise internal quality documentation to comply with all application regulations • Work with R&D and Quality for validation activities • Develops risk assessment review process for all marketed devices and implementation of changes to risk management process as needed • Participates in CAPA program related to complaint handling and adverse event reporting • Perform other duties as need - Prefer Bilingual in English & Korean Here are the benefits: 1. Full Medical Insurance, premium is paid by the company (full access to Aetna or Kaiser) 2. Paid Time Off (5 days of sick leave and 6 days of vacation in first year employment, not including paid holidays which is 8 days a year) 3. 401k Matching (up to 2% of salary) Please send resume to info@sigmagraft.com Contact : Jennie (714)525-0114 ext. 115 I agree to the terms of service Update List
