안녕하세요,

저희는 한국의 코스닥상장사의 미국 자회사로 현지에서 혈당측정기를 판매하고 있습니다.
Medical Device Regulatory 경험있으신분 모집하고 있습니다.

저희는 한국과 베트남에서 혈당측정기 수입하고 있는데 관련한 Regulatory 관리 업무 입니다. JD는 아래쪽 참고 부탁 드립니다.

처우는 경력에 따라 다르겠지만 $100K~$120K 생각하고 있습니다.
401K 6% 매치, 건강보험, PTO, 등 기본적으로 회사에 있는 것들 다 있습니다.
회사 위치는 NH라 소득세가 없고, MA주에 거주하셔도 됩니다.

jlee@agamatrix.com 으로 지원해주세요.
아래는 회사 내규상 JD인데, 실제 상황 옆에 적었습니다.

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.

Responsibilities
• Writing, submitting and gaining approval for products that are class II and In Vitro Diagnostic devices.(본사와 협업이라 여기서 혼자 진행하진 않음)
• Create country specific regulatory submissions for global markets ( 미국은 이미 등록되어있어서 1년에 한번 NB audit대응이고, 타국은 진행 거의 없음)
• 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

Minimum Qualifications
• Bachelor’s degree in biological sciences and/or Medical Technology
• Knowledge of MDD, IVDD, MDR, IVDR and CE Marking.
• 5 to 7 years experience in creating or assisting with 510(k) s and Technical Files.
• Familiarity with domestic and international regulations.
• Practical experience with communications with regulatory agencies and notified bodies.
• Demonstrated knowledge of Quality Management System requirements: FDA Medical Device regulations (QMSR) requirements.
• ISO 13485 and applicable standards.
• Class II Medical device and In Vitro Diagnostic experience.
• Must be enthusiastic, positive and effective in building working relationships with cross functional teams.
• Experience with the application and implementation of (GMP/QMSR/ISO/MDD/IVD and Canadian Medical Device) regulations a plus.