Regulatory Affairs Specialist
insight globalCarlsbad (CA)
About the role
Insight Global is looking for a Regulatory Affairs Specialist that will be responsible for the regulatory functions including support of labeling requirements, serving as regulatory representative on selected project teams. You will also support compilation and submission of regulatory submissions for biologics products primarily but may assist with other product portfolio as needed. Day to
Day Responsibilities:
Provide regulatory guidance to quality systems, manufacturing, marketing and product development groups Represent regulatory on various projects supporting compliance for biologics (Human Tissue Based and Medical Devices) products Provide regulatory guidance to design team for device labeling, promotional materials, and sales training material Prepare and submit regulatory filings for new products or changes to existing products, including management of interactions with regulatory authorities and ensuring that all activities are accurately and timely documented Support compilation and maintenance of design dossiers and technical flies Work with other cross functional members in support of international registrations, renewals and tenders Maintain current knowledge of new regulations, policies, guidance documents, etc. issued by relevant regulatory authorities, which may impact the company Perform other duties as assigned
Must Have
Requirements:
Bachelors Degree 3-5 years of experience in with the biologics or medical device industry in the regulatory affairs field. Experience preparing and submitting documents sent over to government agencies Experience preparing and executing regulatory presentations Experience with blood, human, cell, tissue based products
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