What are the responsibilities and job description for the Regulatory Affairs Specialist position at The Fountain Group?
Pay: 33.58/hr.
Length of Assignment: 2 year contract contract to hire for the right candidate based on performance and need.
Manager is open to candidates willing to relocate at their own expense.
Hybrid 2-3 days on-site, M-F 8am-5pm.
With minimal supervision, manages assigned regulatory tasks related to health authority notifications, submissions, and registrations regarding renewals and new products, and changes to products or sale of products ensuring continual compliance to all applicable regulations and ensuring that site regulatory strategy aligns with overall corporate regulatory strategy, goals, and objectives.
Independently assemble and maintain technical files and other regulatory documentation to ensure timely registrations and renewals.
Monitor the status of standards and regulations. Conduct a review and analysis in case if requested. Assist and advise in activities related to regulatory registrations, listing, and regulatory compliance, with particular focus on In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR; maintaining compliance with requirements of FDA 21 CFR 820, CMDR SOR 98-292, ISO 13485:2016, and other applicable International Medical Device Regulations.
Review updated documentation requirements and carry out documented review, ensuring any necessary updates are made; disseminate relevant information throughout the site.
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