Lead RA&QA Specialist in Seoul at Stryker Corporation

Date Posted: 5/20/2020

Job Snapshot

Job Description

Main objective / purpose of the role:

Process product registration and MRP registration to comply with regulatory compliance before product launch to market. Ensure to maintain Quality Management System of Stryker Korea as NV product is within scope of SKL QMS, and conduct Quality Assurance and Control works related to NV products

List out the key responsibilities / outputs and its respective activities

/input:

  • Describe clearly and concisely

Regulatory Affairs  and Quality Assurance  (RA/QA)

  • Work closely with Korea NV business dept, Stryker NV manufacturers and CDC, and regulatory agencies to control whole process of MFDS registration of NV products
  • Spearhead all procedure of MFDS registration and administrative work precisely and efficiently and  that includes compiling registration submission, filing documents related, keeping, reporting, etc.
  • Manage pre/intra/post-registration works for precise and efficient document control and data management according to SKL RA&QA SOP
  • Provide product registation status and results to business team and related parties within Stryker to help their plan and preparation in advance, Work collaboratively with business team, and Identify and Seek resolution of registration and quality issue for the operational effectiveness
  • Close communicate with MFDS and regulatory agencies to seek resolutions on issues or formal dispute that may arise.
  • Responsible for handling product complaints(PI-Product Inquiry), Product Field Actions(Product Hold, Product Recall, Field Correction, etc.), adverse event reporting, etc to comply with local regulatory requirements and Stryker procedures.
  • Responsible for Korean label complied with local regulations and Ensure Korean IFU preparation with Stryker plants and CDC
  • Represent and participate in MFDS meetings or external meetings with a professional manner
  • Support RA&QA Manager to ensure compliance of SKL QMS per MFDS regulations, ISO 13485 standards, and company standards by supporting the activities related to such as QMS documentation, internal and external audits, training, etc
  • Actively participate in various RA/QA projects internally and externally and lead the group in any chanc, which can have any relation  or impact to NV
  • Closely monitor reglatory trends, regulations change and update, etc and  reflect to MFDS registrations and related works

Reimbursement

  • Process and control overal medical reimbursement registration for NV product and code maintenance in line with government requirements and company strategy
  • Spearhead all procedure of medical reimbursement registration and administrative work precisely and efficiently that includes compiling registration submission, filing documents related, keeping, reporting, etc
  • Manage pre/intra/post-registration works for precise and efficient document control and data management
  • Ensure to maintain NV‘s reimbursement codes list accurately including history and related information and references. And, Ensure all stakeholders can access this info at shared folder in any time when inquired
  • Work collaboratively with business team, and  Identify and Seek resolution of reimbursement issue for the market and business effectiveness, and Provide information and update to business team and related parties within Stryker to help their strategy or preparation in advance
  • Represent and participate in various committees, meetings, and conferences at working level with a professional manner
  • Support reibmursment affairs boss in SKL to manage MRP(medical reimbursement price) strategy and performance
  • Actively participate in various projects related to medical reimbursement affairs externally and lead the group in any chance, which can have any relation  or impact to NV
  • Closely monitor policy trends, regulations change and update, etc and  reflect to NV reimbursement registration and maintenance.

Functional Knowledge / Talents

Academic qualifications / degree & relevant prior experience:

Key talents /strengths for the role:

* University graduated, preferred the majors related to science, engineering, medical, etc.

* Preferred RA/QA/Reimbursement experience in healthcare industry at 1~2 years

* Relevant experience dealing with external parties such as government officials or HCPs

* Well-organized and logical thinking but not arbitrary in planning and processing

* Passionate and a great sense of responsibility

* Strategic and planning skills

* Committed to punctuality and discipline, Detailed oriented

* Professional communication skills

Work From Home: Not available

Travel Percentage: None

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