Safety Control Associate (Fixed Term) at Intuitive

Seoul, , South Korea -

Full Time

Start Date

Immediate

Expiry Date

27 May, 26

Salary

0.0

Posted On

26 Feb, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Product Safety Control, Quality Records Management, Local Labeling Management, ISK QMS Compliance, Regulatory Affairs Collaboration, Complaint Reportability Assessment, Adverse Event Reporting, Health Authority Management, Failure Analysis Letter Review, Post-Market Surveillance, Local Label ACCS Archiving, Package Structure Database Management, Korean Medical Device Act Knowledge, ISO13485 Knowledge, English Communication, Korean Communication

Industry

Medical Equipment Manufacturing

Description

Company Description 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. Job Description 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• 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

Responsibilities

This role manages product safety information, quality records, and local labeling, ensuring compliance with the Intuitive Quality Manual and ISK QMS procedures. Key duties include product complaint assessment, adverse event reporting to health authorities, and managing local regulatory compliance tasks.