Regulatory Affairs Associate

Purpose
This position is responsible for providing Regulatory Affairs support in the design, development, and manufacture and post-market activities.
Responsibilities
• Assist with domestic and international regulatory submissions.
• International device registration and preparation of device dossiers for approval and maintenance of commercial distribution
• Assist with literature and label approval
• Assist with worldwide adverse incident reporting (Vigilance/MDR reporting)
• Assist with Quality Management System and regualtory audits of VitalConnect
• Assure compliance with developing international and federal regulatory requirements and guidelines and with existing regulatory approvals
• Interact with multi-function project teams and corporate partners
Education

• Requires a Bachelor’s Degree

Experience

• 2 years minimum experience in a medical device environment

Knowledge and Training

• Working knowledge of regulations, standards and guidelines related to regulatory affairs
• Ability to use word processing, spreadsheet programs, and email such as MS Office and Excel