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.

Job Responsibilities

• 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)

Qualifications

• 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