**General Description:** The Senior Manager, Regulatory Diagnostics will lead the development, planning, and execution of IVD related regulatory deliverables in line with program strategies and cross-functional initiatives. This individual will represent Regulatory Diagnostics on cross-functional teams, provide guidance on regulatory strategy and tactics, and coordinate with key stakeholders, as required. The Senior Manager will also lead Regulatory Diagnostics initiatives, authoring of IVD related regulatory documentation, and will partner with regulatory team members for management of regulatory documentation and submissions. Externally, this individual will interface with device partners and applicable regulatory agencies/HAs. **Essential Functions:** + Develop and implement strategies for the earliest possible approvals/clearance of regulatory submissions associated with IVD device use for assigned studies. + Gain required clearances for IVD device use for assigned studies. + Manage the preparation, including writing as necessary, assembly, review, and timely submission of regulatory documentation as required for investigation and registration of products in the US and abroad. + Ensure the accuracy of IVD device language for protocols, ICFs, and related study documentation. + Ensure regulatory submissions are maintained in compliance with regulatory requirements. + Address device inquiries from FDA/HAs, IRBs/sites, and partners. + Support and manage preparation of IVD device aspects for meeting requests and briefing documents. + Lead interactions/meetings with FDA, device partners, and others for included device(s) as applicable. + Support study teams by providing expertise on regulatory matters related to IVD device use and associated risks; advise teams on device strategy. + Coordinate with device partners for device use and filings/registrations as applicable. + Maintain IVD medical device regulatory knowledge and advise management and related stakeholders of significant developments. + Prepare and maintain regulatory archives. + Work with external IVD device partners, regulatory consultants, and CRO’s as required. **Knowledge & Skills:** • Working knowledge of FDA and ICH regulatory guidance and regulations. + Understanding of FDA structure and functions; knowledge of/experience with regulatory requirements for other regions also desirable. + Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism. + Experience with MS Office Suite and publishing documents in Adobe Acrobat Professional. + Experience with CTD/eCTD + Excellent verbal and written skills; able to analyze, define, and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to be internal and external stakeholders. + Skilled in conflict resolution/negotiation, fosters open communication; listens, and facilitates discussion. + Strong negotiating skills and ability to think creatively and develop creative solutions. + Proven ability to build trust and respect within the organization. • Ability to prioritize and handle multiple projects simultaneously. + Experienced with interactions with external business partners and regulatory agencies. + CDx development and submission experience strongly preferred. **Experience:** + Bachelor's Degree required with a minimum of 7 years of experience in the biotechnical or pharmaceutical industry and minimum of 4 years of experience in a regulatory capacity, or 7 years of direct experience with in-vitro diagnostic development / companion diagnostics. + Preferred candidates will have regulatory affairs experience with companion diagnostics and biomarker development. **Travel:** Minimal travel (<10%). All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.