- Haemonetics Corp (Boston, MA)
- …Ph.D. or MS in relevant fields and 2-4 years of experience in IVD development. The position entails collaboration with engineers and scientists, ensuring compliance ... with regulatory standards, and managing laboratory practices. A competitive salary range of $101K to $137K annually is offered, along with a robust benefits package. #J-18808-Ljbffr more
- Haemonetics Software Solutions (Boston, MA)
- …The candidate will apply advanced scientific principles in whole blood hemostasis testing and will work collaboratively within a multidisciplinary team to solve ... complex challenges in a fast-paced environment. A strong academic background in bioengineering, biochemistry, or analytical chemistry is required along with relevant experience in assay development and device integration. #J-18808-Ljbffr more
- haemonetics (Boston, MA)
- …contributing to the design and development of an in vitro diagnostic ( IVD ) device. This role involves applying advanced scientific principles and creating reliable, ... Key Responsibilities Design and Development Contribute to the development of IVD assays and devices from concept through commercialization. Work independently and… more
- Haemonetics Corp (Boston, MA)
- …contributing to the design and development of an in‑vitro diagnostic ( IVD ) device. This role involves applying advanced scientific principles and creating ... Key Responsibilities Design and Development: Contribute to the development of IVD assays and devices from concept through commercialization. Work independently and… 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 in ... a medical device/diagnostics or other regulated environment. Direct experience with IVD instrumentation is a plus. Strong knowledge of cybersecurity technologies and… more
- Abbott Laboratories (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
- Haemonetics Software Solutions (Boston, MA)
- …contributing to the design and development of an in vitro diagnostic ( IVD ) device. This role involves applying advanced scientific principles and creating reliable, ... accurate, and regulatory-compliant clinical diagnostic solutions in whole blood hemostasis testing. The focus of this position will be to evaluate and develop novel assay designs to drive innovative solutions to complex issues. This individual will be both a… more
- Delve Bio, Inc. (San Francisco, CA)
- …molecular laboratory developed tests (LDT) or in vitro diagnostics ( IVD ) Experience working with interdisciplinary teams (software engineering, bioinformatics, ... medical, R&D, commercial, quality, product development, etc.) Experience with agile methodologies (Scrum, Kanban) is a plus. Experience working with external medical providers enabling EMR/EHR data integrations (HL7/FHIR) Experience working with and… more
- Fapon (Boston, MA)
- …has historically focused on three major businesses: raw material solutions, IVD ecosystem platform service, and intelligent digital diagnosis and treatment. Fapon ... recently received IND approval from the FDA for a differentiated CD47 antibody drug, the first in a rapidly expanding therapeutics effort. It has a global footprint in Beijing, Shenzhen, Shanghai, the United States, Germany, India, and other locations… more
- 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
- Amgen (Thousand Oaks, CA)
- …of patients while transforming your career. **Director, Regulatory Affairs - In-Vitro Diagnostics ( IVD )** **What you will do** Let's do this. Let's change the world. ... Key responsibilities will include: **Responsibilities** + Manage and mentor the IVD regulatory affairs team, fostering talent retention and promoting a culture… more
- GRAIL (Dover, DE)
- …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
- Takeda Pharmaceuticals (Lexington, MA)
- …of my knowledge. **Job Description** **OBJECTIVES / PURPOSE** The SaMD and IVD Principal Manager is an experienced quality and technical professional responsible ... (DQ) function to support software medical devices (SaMD), in vitro diagnostics ( IVD ), and combination products across all phases of the product lifecycle-design,… 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
- Nanobiosym, Inc. (Cambridge, MA)
- …or related field + Minimum of 7 years of relevant industry experience and IVD assay development + In depth knowledge and hands on experience with qPCR, sequencing ... and standard molecular biology techniques + Demonstrated technical, managerial and leadership expertise in assay development + Strong understanding of FDA and global regulatory requirements + Prefer commercial assay experience + Demonstrated experience and… 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
- IQVIA (Durham, NC)
- …The Project Lead is responsible for ensuring that all studies are designed, planned, executed, monitored, closed out and documented in an appropriate manner within ... the planned timeframe and cost; ensuring that the sponsor responsibilities are fulfilled, while assuring compliance to all applicable regulatory requirements. Responsible for the timeline and budget planning and execution of studies. Assigns and ensures… 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
- Actalent (Broomfield, CO)
- …Program Manager to drive the execution of complex in vitro diagnostics ( IVD ) validation and regulatory programs supporting an extensive autoimmune diagnostics test ... management for FDA and IVDR submission programs supporting autoimmune IVD products. + Coordinate closely with the project management...for FDA and IVDR filings across an extensive autoimmune IVD test menu. + Ensure alignment of study designs,… more
- Actalent (Broomfield, CO)
- …Program Manager to drive the execution of complex in vitro diagnostics ( IVD ) validation and regulatory programs supporting an extensive autoimmune diagnostics test ... management for FDA and IVDR submission programs supporting autoimmune IVD products. + Coordinate closely with the project management...for FDA and IVDR filings across an extensive autoimmune IVD test menu. + Ensure alignment of study designs,… more
