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 authoritys 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.
 

Qualifications :

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
Bachelors degree in science engineering medical engineering or related

Working Conditions
None

Preferred Skills and Experience 
Experience in SAP TrackWise

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.

Remote Work :

No

Employment Type :

Contract