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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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When you’re working Regulatory Affairs Manager jobs, Regulatory Affairs Director jobs, as a Regulatory Affairs Manager, Senior Regulatory Affairs Manager, or Regulatory Affairs Project Manager, you’ll take on the role of diligently monitoring your company or organization’s production activities to ensure compliance with various applicable regulations and standard operating procedures. In Regulatory Affairs Manager jobs, you’ll oversee regulatory submissions, making sure they accurately and completely comply with regulations dictated by government bodies and other entities. You’ll prepare and file the submission documents and assist with external audits to ensure compliance. You will also respond to any potential complaints regarding devices and products. Finally, you’ll manage a team or teams who will assist you in achieving any and all regulatory endeavors by monitoring their performance and output to ensure your company or organization’s continued success.
Regulatory Affairs Manager Roles and Responsibilities
Regulatory Affairs Manager Skills and Qualifications
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