Primary Function of Position
The position is responsible for product safety information management, 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
Product safety control
• Product complaint reportability assessment and/or approval
• Additional safety information collection from customers
• Product complaints, adverse event reporting to health authority designated organization according to ISK QMS and Korea medical device regulations
• Health authority’s additional information requests management including drafting the answers, submitting the answer documents and maintain the database
• Complaints products RMA shipping coordination
• Review and translate Failure Analysis(FA) letters. Deliver the FA letter to customers and communicate with them.
• Local credit decision supporting materials preparation
• Maintain post-market surveillance-related local database including adverse event database
• Participate in local or global’ s product safety control efficiency/compliance improvement
projects.
Regulatory compliance
• Manage local label ACCS archiving procedure
• Manage package structure & raw material database and annual reporting of the package structure & raw material and waste weight to relevant government agencies according to the local regulations.
Required Skills and Experience
• Preferred <3 years of relevant RAQA experiences in the medical device industry.
• Knowledge of Korean Medical Device Act & related regulations/guidelines and ISO13485
• Excellent verbal and written communication both in English and Korean & interpersonal skill
to work well with cross-functional teams
• Ability to work in a fast-paced environment and handle multiple projects simultaneously
• Orientation for work result details, with emphasis on accuracy and completeness
Required Education and Training
• Bachelor’s degree in science, engineering, medical engineering or related
Working Conditions
None
Preferred Skills and Experience
• Experience in SAP, TrackWise
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.
At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible. Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential. Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.
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