Kelly
Principal, Regulatory Affairs - Transfusions
Kelly Services is proud to offer a direct hire opportunity in the Norcross, GA area for a Principal, Regulatory Affairs (Transfusion). Principal, Regulatory Affairs
IVD / Medical Devices Location: Norcross, GA Industry: Medical Devices / In Vitro Diagnostics Pay: $100k-$130k About the Role We are seeking a highly skilled Principal, Regulatory Affairs professional to manage pre-market regulatory activities for medical devices, including in vitro diagnostics (IVDs). The role will support global regulatory compliance across US FDA, Health Canada, and EU Notified Body requirements, providing regulatory guidance throughout product development and launch. This position serves as a key regulatory partner on design teams, authors regulatory submissions, reviews product labeling and commercial materials, and interfaces with regulatory agencies to ensure compliance. Key Responsibilities Serve as regulatory representative on design teams for new products and significant product modifications. Develop global regulatory plans, advising on product classification, registration paths, and commercial strategy alignment. Prepare and submit regulatory filings, including US FDA 510(k), Health Canada licenses, and EU Notified Body submissions. Author summary analytical and clinical reports, and coordinate submission deliverables with R&D and Marketing. Review and approve commercial materials (brochures, presentations, training materials) for regulatory compliance. Maintain awareness of regulatory requirements across the US, Canada, and EU, and support ongoing product launches. Perform other regulatory activities as needed to support compliance and successful market entry. Qualifications Bachelor's degree in regulatory science, life sciences, or related field (advanced degree preferred). Minimum 8 years of regulatory affairs experience in medical devices, preferably with IVD experience. Hands-on experience preparing submissions to US FDA, Health Canada, and EU Notified Bodies within the past 8 years. Knowledge of FDA 21 CFR 820, Health Canada Medical Device Regulations, MDSAP, and exposure to EU MDR/IVDR. Strong writing, verbal communication, and organizational skills. Ability to prioritize multiple projects in a fast-paced environment with minimal supervision. English fluency required; international travel 510% per year. Additional Details Travel Requirement: 510% domestic and international Employment Type: Full-time, permanent
Kelly Services is proud to offer a direct hire opportunity in the Norcross, GA area for a Principal, Regulatory Affairs (Transfusion). Principal, Regulatory Affairs
IVD / Medical Devices Location: Norcross, GA Industry: Medical Devices / In Vitro Diagnostics Pay: $100k-$130k About the Role We are seeking a highly skilled Principal, Regulatory Affairs professional to manage pre-market regulatory activities for medical devices, including in vitro diagnostics (IVDs). The role will support global regulatory compliance across US FDA, Health Canada, and EU Notified Body requirements, providing regulatory guidance throughout product development and launch. This position serves as a key regulatory partner on design teams, authors regulatory submissions, reviews product labeling and commercial materials, and interfaces with regulatory agencies to ensure compliance. Key Responsibilities Serve as regulatory representative on design teams for new products and significant product modifications. Develop global regulatory plans, advising on product classification, registration paths, and commercial strategy alignment. Prepare and submit regulatory filings, including US FDA 510(k), Health Canada licenses, and EU Notified Body submissions. Author summary analytical and clinical reports, and coordinate submission deliverables with R&D and Marketing. Review and approve commercial materials (brochures, presentations, training materials) for regulatory compliance. Maintain awareness of regulatory requirements across the US, Canada, and EU, and support ongoing product launches. Perform other regulatory activities as needed to support compliance and successful market entry. Qualifications Bachelor's degree in regulatory science, life sciences, or related field (advanced degree preferred). Minimum 8 years of regulatory affairs experience in medical devices, preferably with IVD experience. Hands-on experience preparing submissions to US FDA, Health Canada, and EU Notified Bodies within the past 8 years. Knowledge of FDA 21 CFR 820, Health Canada Medical Device Regulations, MDSAP, and exposure to EU MDR/IVDR. Strong writing, verbal communication, and organizational skills. Ability to prioritize multiple projects in a fast-paced environment with minimal supervision. English fluency required; international travel 510% per year. Additional Details Travel Requirement: 510% domestic and international Employment Type: Full-time, permanent