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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 Regulatory Affairs Associate.
Job Summary
To provide knowledge and experience with creating/revising Design History Files, and CE files, updating internal procedures and other documents for changes in both FDA and EU regulations and working with other departments for validation activities to meet regulatory requirements.
Key Responsibilities
• Provides guidance on regulatory requirements necessary for strategic and contingency planning, including developing regulatory strategic plans to R&D and Quality Departments for solutions.
• Register new products by working with regulatory agencies and notified bodies for product commercialization
• Work with R&D to prepare DHF, CE, and Risk Management Files
• Conduct literature reviews for CER files and for Post Market Surveillance
• 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 neededSkills & Knowledge Requirement
• A 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 preferred.
• Adaptable to a fast-paced environment with changing circumstances, direction, and strategy and has the desire to thrive in a dynamic environment.
• Strong interpersonal, written, and oral communication skills.OPT 보유분 지원 – Sponsorship 가능
Please submit your resume or questions to sgadmin@sigmagraft.com.