Regulatory Affairs Associate
📋 Role Overview & Responsibilities
Job Description:Shift: Monday-Friday 1st shift (This is a hybrid role manager is looking for someone to go onsite 2-3 days a week)This is a temporary assignment that is slated for 1 year with possibility for extension or conversion based on performance and budget.Position is responsible for managing 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.Position is also responsible for assembling and maintain technical files and other regulatory documentation to ensure timely registrations and renewals. Including, monitoring 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.
Qualifications:Bachelor’s or master’s degree within pharmacy, biology, engineering, or other life sciences. At least 1 year of experience within regulatory affairs. (IVD experience preferred)
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This position is located in St Louis, MO with potential relocation and sponsorship assistance depending on candidate qualifications.
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