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Our client is looking for a Regulatory Affairs Manager to join their growing team. This company is at the cutting edge of medical device solutions through their unique product line making waves around the industry
Harness your regulatory expertise across the product lifecycle, molding CMC strategy. Lead manufacturing change assessments, guide site expectations, drive the TSE/BSE program, and craft robust compliance documents for impactful Health Authority submissions.
Provide regulatory expertise through all stages of the product lifecycle, including development of CMC strategy. Perform regulatory assessments for manufacturing changes, provides guidance on regulatory expectations for the site, oversees the TSE/BSE program, and provides compliance documents to support Health Authority submissions
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