글로벌 바이오제약회사에서 다음과 같이 ‘Device Expert’를 찾습니다.
~ Title: Device Expert
~ Department: Drug Product Group
~ Report to Group Head
~ Experience: over 15 years
Summary of Job Purpose
• Lead and perform risk control, risk management, and design history file management related activities for the development of medical device and combination products following design control process and regulatory requirements.
• Provide expertise to design and development of devices and combination products and manage the relevant processes to comply with applicable guidelines.
• Assures that quality and compliance policy of company and applicable regulations are met by means of independent risk management for medical devices under development.
• Oversight design control during the device development, design control and design transfer.
• Lead, plan and perform risk management in medical device projects in ensuring that risk management is performed in sufficient detail and in a timely manner for new device introductions and regulatory agency inspections.
• Advise new projects in setting up design control documentation and design history file structure.
• Support projects with compliance to medical device and combination product quality standards and regulatory guidance and directives
• Provide expertise on documentation to ensure compliance to relevant regulations
• Design and implement design control document templates
• Ensure that risk control measures are implemented, verified, and validated.
• Confirm that the risk management process incorporates all relevant data from the Device Design
• Support creation of device design specifications to ensure that risk control measures are appropriate.
• Review and support task analysis, hazard identification, use error analysis to ensures that hazards associated with a medical device are identified, the associated risks are estimated and evaluated and that these risks are controlled
• Confirm the fulfillment of the regulatory requirements
• Ensure the integrity of design history file and risk management file
• Monitor release of new applicable standards and regulations and maintain knowledge of standards and guidelines as well as industry practices, regulatory requirements, and other relevant information.
• Ensure harmonized approaches to risk management across projects. Communicate with multiple teams on multiple projects to share lessons learned and ensure use of common tools and ideas within the team.
• Support a good link between risk management during development and risk management for Marketed products.
• Support strategy of CTD with the regulatory affairs team and review CTD sections related to device
• Support answer strategy, review/write answer document to Agency’s questions related to device (e.g. IRs)
• Minimum of bachelor’s degree or equivalent in science or engineering or similar field
• Successfully demonstrated several years experience in pharmaceutical or medical device industry (minimum 6 years) in the development, submission and commercialization of medical devices or combination products.
• Extensive knowledge of and experience in performing risk management for medical devices
• Proficient in usage of risk assessment methods, e.g. Failure Modes and Effects Analysis (FMEA)
• Extensive knowledge of international medical standards, e.g. ISO 14971, ISO 13485, IEC 62366, ANSI/AAMI HE75, and FDA guidelines
• Managing ability for planning, development, and control of CMO
• Good verbal and written communication skills
• Culturally aware and ability to think and work globally
• Strong Analytical Skills
• Fluent In English
Those who are interested in this opportunity, please submit your Resume in MS Word Format by email urgently Only qualified candidates will be contacted for interview All resumes not contacted will be kept in DB confidentially for future positions
Kyung Jin KIM
CEO & Executive Search Consultant