Safety Control Associate (Temp)

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.