- Grifols Shared Services North America, Inc (San Diego, CA)
- …compliance and supporting global market access for in vitro diagnostic ( IVD ) products. It involves developing and executing regulatory strategies, preparing and ... years of direct experience in Regulatory Affairs. Prior experience in the IVD or Drug/Biologics industry is required. **Primary responsibilities for role:** +… more
- GRAIL (Albany, NY)
- …monitors and communicates changes in regulatory policies and In Vitro Diagnostic ( IVD ) requirements to project teams and leadership. They may manage and provide ... regulatory, development, clinical affairs, quality, or program management within the IVD , medical device, or pharmaceutical industries is required. + Regulatory… more
- ICON Clinical Research (NC)
- Senior Manager, Regulatory Affairs - IVD ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive ... mission to shape the future of clinical development. Sr Manager, Regulatory Affairs - IVD Location: US Remote, Portland, OR area preferred We are currently seeking a… more
- Kelly Services (Norcross, GA)
- …Four to ten years of related work experience. + Experience in IVD development (software/system/assay focus) required + Science or Engineering Degree Preferred ... **Skills & Capabilities:** + Excellent written and verbal communication skills. + Excellent analysis, troubleshooting, and debugging skills. + Ability to perform in a fast-paced, agile environment. + Ability to operate independently and exercise good judgment… more
- Sanofi Group (Morristown, NJ)
- …supporting the medical device, combination product, digital health and in-vitro diagnostic ( IVD ) products within the Sanofi portfolio of products. The team is part ... team is accountable for developing and implementing global regulatory strategies for device and IVD products, intended to be used alone or in combination with a drug… more
- IQVIA (Wayne, PA)
- …on delivering tailored solutions to the **medical device and in vitro diagnostics ( IVD ) industries** . The **MedTech Mid-Market Account Manager** will play a pivotal ... account expansion** across a defined portfolio of **In Vitro Diagnostics ( IVD ) clients - including Diabetic Care, Oncology-related Molecular and NGS Testing,… more
- Caris Life Sciences (Tempe, AZ)
- …and RA. + Support analytical verification and validation (V&V) studies for oncology-focused IVD assays: + Contribute to study design and sample planning. + Draft and ... with Design Control and product development within a regulated ( IVD or medical device) environment. + Ability to work...ISO 13485, FDA QSR, or IVDR. + Experience with IVD or SaMD product development and regulatory submissions (510(k),… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …collaborating closely with pharmaceutical partners to design, develop, and validate IVD companion diagnostics aligned with targeted drug therapies. The ideal ... candidate will bring expertise in IVD product development, design control, and regulatory compliance, with...5 years of experience in Quality Engineering within the IVD or medical device industry. + Strong knowledge of… more
- ThermoFisher Scientific (Rockville, MD)
- …The Clinical Diagnostics Division (CDD) provides innovative diagnostic solutions for select IVD market segments and has been a trusted supplier in the ... IVD industry for over 40 years. The division provides...of the world's largest suppliers of in vitro diagnostic ( IVD ) products rely on us as their OEM and… more
- ThermoFisher Scientific (Austin, TX)
- …2-4 years of proven experience in Animal Health Diagnostic (preferred) or Human IVD Regulatory Affairs. This experience may include a combination of Animal Health ... VDx as well as US IVD and CE- IVD experience. + Demonstrated ability to maintain regulatory permits and licenses. + Proficiency in preparing regulatory compliance… more
- Sanofi Group (Morristown, NJ)
- …supporting the medical device, combination product, digital health and in-vitro diagnostic ( IVD ) products within the Sanofi portfolio of products. The team is part ... team is accountable for developing and implementing global regulatory strategies for device and IVD products, intended to be used alone or in combination with a drug… more
- BD (Becton, Dickinson and Company) (San Jose, CA)
- …in process improvement, best practices, and change management within the Medical Device/ IVD industries + Sales and/or marketing experience in Medical Device/ IVD ... industries + Duties require ability to integrate projects within BDX Sales Organizations and Marketing Departments **Knowledge and Skills:** Customer Centricity: + Strong knowledge of health care trends; Customer focused problem solving; Strong customer… more
- LGC Group (Milford, MA)
- …materials for the extended life sciences industry. We partner with IVD assay developers, pharmaceutical, CRO and academic institutions in commercialization ... and Technopath Clinical Diagnostics, which are in vitro diagnostics ( IVD ) manufacturers of quality measurement tools (calibrators, controls, linearity, EQA/PT,… more
- Roche (Indianapolis, IN)
- …will be the key strategic partner driving market access for our life-changing IVD products in major global markets, primarily the US and Europe. **The Opportunity** ... registration plans. + For this specific role, you ensure that Roche IVD products, systems and software, particularly Companion Diagnostics, receive timely regulatory… more
- Bristol Myers Squibb (Princeton, NJ)
- …scientific and regulatory expertise (US, EU, Canada, PMD, TGA or Global Devices/ IVD preferred), cross-functional leadership, and a commitment to innovation in early ... diagnostics and biomarkers, with deep expertise in assay and IVD development-including analytical validation, clinical development, manufacturing, and global… more
- Hologic (San Diego, CA)
- …related to Design Control efforts in accordance with FDA, ISO, and other IVD regulations. You will also support the company's quality system activities and design ... control/quality product design experience in a regulated environment, ideally in the IVD space. + Working knowledge of Quality Management System for Medical Device… more
- Abbott (San Diego, CA)
- …preferably in a medical device/diagnostics or other regulated environment. Direct experience with IVD instrumentation is a plus. * Minimum of 10 years of experience ... a medical device/diagnostics or other regulated environment. Direct experience with IVD instrumentation is a plus. * Strong knowledge of cybersecurity technologies… more
- Kelly Services (Norcross, GA)
- …area for a Principal, Regulatory Affairs (Transfusion).** Principal, Regulatory Affairs - IVD / Medical Devices Location: Norcross, GA Industry: Medical Devices / In ... 8 years of regulatory affairs experience in medical devices, preferably with IVD experience. * Hands-on experience preparing submissions to US FDA, Health Canada,… more
- Danaher Corporation (Deer Park, IL)
- …time to time, support matters for other Danaher operating companies in the Diagnostic/ IVD and Life Sciences markets. Essential Qualifications + JD from an accredited ... at all levels of the company. Preferred Qualifications + Experience in the diagnostic/ IVD industry. + Experience in the medical device industry. + Experience with… more
- GRAIL (Menlo Park, CA)
- …initiation and execution + Industry experience within in vitro diagnostics ( IVD ) highly preferred; pharmaceutical, biologics or medical device experience also ... acceptable + Thorough knowledge of GCP, ICH guidelines and other US and international clinical regulatory requirements + Working experience with an electronic data capture system, CTMS system, and eTMF system. + Strong interpersonal communication (written and… more
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