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​​​​​​ with literature and label approval
• Assist with worldwide adverse incident reporting (Vigilance/MDR reporting)
• Assist with Quality Management System and regulatory 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