The Manager of Regulatory Affairs will develop regulatory strategies for new and modified QIAGEN in vitro diagnostic (IVD) products.
• Prepare regulatory submissions for US and Health Canada approvals for QIAGEN IVD products that include RT-PCR test kits for infectious disease viral markers. Other products include reagents and instrumentation for nucleic acid extraction from biological samples that are linked to downstream IVD test applications
• Review product labeling and promotional literature for regulatory compliance
• Research and interpret regulations, guidelines and precedents to support interdepartmental project teams in developing strategies, policies and procedures that ensure regulatory compliance with FDA, Health Canada and other regulatory agencies in the least burdensome manner
• Interface with regulatory agencies for inquiries and issues
• Review and prepare clinical reports, R&D protocols and technical reports and other company documents (including labeling and marketing materials, when applicable) for use in regulatory submissions and in response to queries from the FDA and Health Canada
• Work closely with Customer Care/Technical Services to ensure quality of information and adequate processing of complaints and establish MDR reporting measures and continuous improvement activities
• Develop regulatory process SOPs relevant for registration of IVD products or other regulatory aspects
• Responsible for ensuring on-going compliance to applicable quality and EHS regulations and standards (e.g., ISO, US FDA, MDD, IVDD, EU-PSHA, OSHA, etc.).