Home Job Postings [뉴햄프셔주] 글로벌 체외진단 기업 – Regulatory Affairs Manager 채용 This topic has replies, 0 voices, and was last updated 4 days ago by ICN Group. Now Editing “[뉴햄프셔주] 글로벌 체외진단 기업 – Regulatory Affairs Manager 채용” Name * Password * Email Topic Title (Maximum Length 80) Company * Location Expires at 미국 전지역에 글로벌 인재채용 서비스를 하고 있는 헤드헌팅 전문기업 아이씨엔그룹입니다. 뉴햄프셔주에 위치한 글로벌 체외진단 기업 미국현지법인에서 경력직을 채용합니다. 관심 있으신 분들의 빠른 지원 부탁 드립니다. <strong>■ 연봉 : </strong> $100K-120K/year <strong>■ 근무지역 :</strong> – Derry, NH <strong>■ 채용분야 :</strong> Regulatory Affairs Manager <strong>■ 직무내용 :</strong> Position Summary: The Regulatory Affairs Manager is responsible for overseeing regulatory strategy and ensuring company products meet all applicable regulatory requirements. This role works cross-functionally to support product development, coordinate with regulatory agencies, and ensure timely regulatory approvals. • Writing, submitting and gaining approval for products that are class II and In Vitro Diagnostic devices. • Create country specific regulatory submissions for global markets • Prepare original technical files and maintain up to date technical files • Review and approve product labeling and advertising for compliance to applicable regulatory requirements • Manage product complaint process per FDA and international regulations • Assist in the decision process for reportable complaints. Complete adverse events documentation (MDR / MDV), and responsible assisting agency closures. • Provide input into product risk/hazards review and design reviews • Prepare Technical Files in support of CE Marking, and product registration for countries outside of Europe • Review and file NFJs (non-filing justifications) for minor changes to 510(k) cleared products or systems. • Provides information and opinion regarding regulatory submissions to Management • Defend company business interest in international standardization groups • Manage transposition of international standards into company product related requirements • Update licensing and collect information on registration instructions and regulations • Provide direction, assign work and assess performance of direct reports • Participate in recruitment process as needed for personnel within the Regulatory team <strong>■ 자격요건 :</strong> – 학사 학위 이상 – Biological Sciences, Medical Technology 등 유관 전공자 지원 가능 – MDD, IVDD, MDR, IVDR 및 CE 인증에 대한 지식 보유 – 510(k) 및 Technical File 작성 또는 지원 경력 5~7년 내외 – 국내외 의료기기 규정에 대한 이해 – 규제기관 및 Notified Body과의 실무 커뮤니케이션 경험 – FDA 의료기기 규정(QMSR) 지식 – ISO 13485 및 관련 표준 지식 – Class II 의료기기 및 체외진단기기(IVD) 경험 – MP / QMSR / ISO / MDD / IVD / 캐나다 의료기기 규정 적용 및 운영 경험 우대 <strong>■ 베네핏 :</strong> • Benefits may vary depending on the company’s benefits program • 401k match 6% • Medical / Dental / Vision Insurance 85% • Paid Vacation, Unlimited PTO <strong>■ 지원방법 : </strong>이메일 영문이력서 제출 / icngroup@icncareer.com [이메일 제목] WorkingUS+성함+지원포지션 [이메일 내용] 현재 Status 및 희망 포지션/희망근무지역/연봉조건/연락처 기재 , 해당 공고 Link 기재 ※ 미국 취업에 결격 사유 없는 지원자(OPT, STEM OPT, CPT, E-2 Transfer, H1B, Green Card, Citizen)만 지원 가능합니다. 지원 관련하여 문의 사항이 있으시면 위에 이메일로 연락 주시기 바랍니다. 감사합니다. I agree to the terms of service Update List
