Jacobs Management Group
Senior Manager Regulatory Affairs Regulatory Affairs Leader
Jacobs Management Group, Lincolnshire, Illinois, United States, 60069
Are you ready to lead regulatory strategies that will have a global impact? Join my client as a Senior Manager in Regulatory Affairs, where you’ll be at the forefront of innovation in the medical device industry. Take this opportunity to shape the future of healthcare by ensuring compliance with FDA and Health Canada regulations, and by leading a dynamic team focused on continuous improvement.
Why You Should Apply:Lead and shape regulatory strategies for cutting-edge medical devices.Work directly with regulatory agencies in the US and Canada.Collaborate with cross-functional teams to drive product success.Manage and mentor a team of regulatory affairs professionals.What You’ll Be Doing:Leading the preparation, documentation, and submission of FDA and Health Canada applications.Managing device establishment registrations and ensuring ongoing compliance.Providing regulatory guidance on product development and marketing strategies.Overseeing regulatory procedures and implementing continuous process improvements.Supporting post-approval products through change evaluation and submission.About You:7+ years of progressive experience in regulatory affairs.Must have experience with in vitro diagnostics (IVDs)Thorough understanding of FDA, Health Canada regulations, and the 510(k) process.Expertise in Hematology, Urinalysis, Flow Cytometry, and Coagulation is a plus.Ability to communicate complex scientific data effectively.Proven leadership skills with experience in team management.How To Apply:We’d love to see your resume, but we don’t need it to have a conversation. Send an email to ccupo@jacobsmgt.com and tell me why you’re interested. Or, if you do have a resume ready, apply here.
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Why You Should Apply:Lead and shape regulatory strategies for cutting-edge medical devices.Work directly with regulatory agencies in the US and Canada.Collaborate with cross-functional teams to drive product success.Manage and mentor a team of regulatory affairs professionals.What You’ll Be Doing:Leading the preparation, documentation, and submission of FDA and Health Canada applications.Managing device establishment registrations and ensuring ongoing compliance.Providing regulatory guidance on product development and marketing strategies.Overseeing regulatory procedures and implementing continuous process improvements.Supporting post-approval products through change evaluation and submission.About You:7+ years of progressive experience in regulatory affairs.Must have experience with in vitro diagnostics (IVDs)Thorough understanding of FDA, Health Canada regulations, and the 510(k) process.Expertise in Hematology, Urinalysis, Flow Cytometry, and Coagulation is a plus.Ability to communicate complex scientific data effectively.Proven leadership skills with experience in team management.How To Apply:We’d love to see your resume, but we don’t need it to have a conversation. Send an email to ccupo@jacobsmgt.com and tell me why you’re interested. Or, if you do have a resume ready, apply here.
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