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Job description
We are a manufacturer of biomedical devices specializing in the manufacture of dental and orthopedic biomaterials used in bone regeneration.We are looking for a Research Associate.
Key Responsibilities of a Research Associate
Guide regulatory requirements necessary for strategic and contingency planning, including developing regulatory strategic plans for R&D and Quality Departments for solutions.
Register new products by working with regulatory agencies and notified bodies for product commercialization
Create/revise internal quality documentation to comply with all applicable regulations
Work with R&D and Quality for validation activities
Develops risk assessment review process for all marketed devices and implementation of changes to risk management process as needed
Participates in CAPA program related to complaints handling and adverse event reporting
Perform other duties as needed
Skills & Knowledge RequirementsA Bachelor’s Degree (B.S or B.A) required; in Engineering, Science or equivalent focus preferred.
A minimum of 1 year of experience in a regulated industry is required; preferably with medical devices.
Demonstrated strong time and project management skills with the ability to multitask.
Understanding and awareness of FDA, Health Canada, and European medical device regulations/standards/directives are preferred.
Adaptable to a fast-paced environment with changing circumstances, direction, and strategy and has the desire to thrive in a dynamic environment.
Bi-lingual in Korean(Preferred but not required)
Strong interpersonal, written, and oral communication skills.
Job Type: Full-timeOPT 소지자 Sponsorship 가능
Benefits:
401(k) matching
Health insurance
Paid time off
Schedule:8 hours shift
Experience:Work Location: One location
Please submit the application or question to sgadmin@sigmagraft.com.