Job Description
Primary Function of Position
The position is responsible for quality management activities, including but not limited to site registration, quality records management, local labeling management. Also responsible for managing and implementing necessary measures to comply with the Intuitive Quality Manual and related internal procedures under ISK Quality Management System (“ISK QMS”).
Closely collaborate with Regulatory affairs, Commercial, Customer Service and SCM.
Essential Job Duties
Regulatory compliance & QMS management
- Support internal QMS monitoring
- Follow up all post auditing activities and drives the execution of corrective action and preventive action, ensuring the timely closure of CAPA/ARF actions.
- Closely communicate with regulatory agencies to seek resolutions on quality issues or formal disputes that may arise.
- Manage local IFUs archiving process and conduct regular internal labeling monitoring
- Review & approve product release, return, scrape, preowned device report and manage the related records to comply to the local regulations, ISK QMS and Global guidelines.
- Regularly train 3rd parties involved in quality activities to ensure the GSP compliance.
- Cooperate with Safety control team to assess the product complaints and reduce the product complaints
- Participate in local or global quality efficiency improvement projects.
Site registration
- Support all procedures of site registration including new site registration, change management, renewals, after-approval administrative work precisely and efficiently, including strategy set up, compiling submission dossier, communication with the responsible health authority/notified bodies, safety stock building in cooperation with responsible functions, documents archiving, reporting, etc.
- Support or manage on-site or desktop audits.
- Provide regulatory input to stakeholders within ISI & ISK to support business planning, product stock management, etc
Qualifications
Essential Job Duties
Regulatory compliance & QMS management
- Support internal QMS monitoring
- Follow up all post auditing activities and drives the execution of corrective action and preventive action, ensuring the timely closure of CAPA/ARF actions.
- Closely communicate with regulatory agencies to seek resolutions on quality issues or formal disputes that may arise.
- Manage local IFUs archiving process and conduct regular internal labeling monitoring
- Review & approve product release, return, scrape, preowned device report and manage the related records to comply to the local regulations, ISK QMS and Global guidelines.
- Regularly train 3rd parties involved in quality activities to ensure the GSP compliance.
- Cooperate with Safety control team to assess the product complaints and reduce the product complaints
- Participate in local or global quality efficiency improvement projects.
Site registration
- Support all procedures of site registration including new site registration, change management, renewals, after-approval administrative work precisely and efficiently, including strategy set up, compiling submission dossier, communication with the responsible health authority/notified bodies, safety stock building in cooperation with responsible functions, documents archiving, reporting, etc.
- Support or manage on-site or desktop audits.
- Provide regulatory input to stakeholders within ISI & ISK to support business planning, product stock management, etc
Additional Information
Intuitive는 고용 기회 균등 고용주입니다. 당사는 인종, 성별, 임신 여부, 성적 지향, 성 정체성, 출신 국가, 피부색, 연령, 종교, 국가 보훈 대상자, 장애 여부, 유전 정보 또는 연방, 주 또는 현지 관련 법률에 따라 보호받는 기타 모든 지위에 관계없이 자격을 갖춘 모든 지원자 및 직원에게 동등한 고용 기회를 제공하며 모든 유형의 차별과 괴롭힘을 금지합니다.
당사는 기회 균등법에 따라 범죄 및 유죄 판결 기록이 있는 고용 자격을 갖춘 지원자를 고려할 것입니다.