- ICON Clinical Research (Farmingdale, NY)
- …people in the sector, and you'll be helping shape an industry. ** Regulatory Affairs Manager - In Vitro Diagnostic (IVD) Medical Devices** **The role:** ... As a Regulatory Affairs Manager you will need to be experienced with In Vitro Diagnostic (IVD) Medical Device and CDx directives, regulation, and … more
- Abbott (Princeton, NJ)
- …collaborative study protocol versions with APOC and Principal Investigator(s). The Scientific Affairs Manager will also liaise with cross-functional team members ... including clinical, regulatory , quality, legal, supply chain and will be responsible...training, study design, protocol and/or workflow development. The Scientific Affairs Manager will also support abstract, poster… more
- Danaher Corporation (Dallas, TX)
- …diagnostic tools that address the world's biggest health challenges. The Clinical Affairs Manager for Beckman Coulter Diagnostics is responsible for directly ... You will be a part of the CCIA Clinical Affairs team and report to the Senior Manager...the currently approved protocol/amendment(s), SOPs, GCP, PHI, and applicable regulatory requirements. + Drive clinical schedule deliverables and project… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- … vitro diagnostics and those of associated disciplines (such as R&D, Regulatory Affairs , Quality Assurance, or Project Management). The Specialist, Medical ... possible** with us. **Duties and Responsibilities:** + Works with manager to understand full needs of Medical Affairs...timelines and workload demands, and are in compliance with regulatory requirements + Asserts own ideas and persuades others.… more
- Danaher Corporation (Washington, DC)
- …and clinical trial purposes. + Oversee the acquisition of samples for in vitro diagnostics, ensuring adherence to ethical and regulatory requirements, study ... world's biggest health challenges. The Senior Staff Specimen Acquisition and Inventory Manager for Beckman Coulter Diagnostics plays a crucial in obtaining samples… more
- Abbott (Alameda, CA)
- …Bachelors Degree + Minimum 8 years of Quality Systems, Quality Assurance and/or Regulatory Compliance/ Affairs experience in In Vitro Diagnostics and medical ... and professionals measure, track and analyze glucose levels. As the Alameda Compliance Manager , you will set strategy for internal, clinical, and external audits (… more
- GRAIL (Durham, NC)
- …but not limited to Quality, Clinical Laboratory Operations, Technical Operations, Regulatory Affairs , Compliance, Program Management, Clinical Affairs , ... concepts in accordance with GRAIL's quality management system and regulatory requirements including ISO 13485, In Vitro ...and regulatory requirements including ISO 13485, In Vitro Diagnostic Regulation, ISO 14971, 21 CFR 11, 21… more
- Danaher Corporation (Washington, DC)
- …and internal stakeholders, including the US market access team, government affairs , HEOR colleagues, customers, marketing, sales, regulatory and clinical ... Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Manager Market Access Analytics and Enablement will have responsibility… more
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …study data collection, management, and analysis meet the requirements to support regulatory submission of bioMerieux's molecular in vitro diagnostic products or ... writing study reports that will be used to support regulatory submissions. + Represent Clinical Affairs for collaboration with Software teams in review of pouch… more
- ThermoFisher Scientific (Fremont, CA)
- …Thermo Fisher's Niche Diagnostics business unit, you will lead Quality Assurance and Regulatory Affairs related programs and projects in support of harmonization ... and improvement initiatives, and regulatory activities (including domestic and international regulatory submissions. In this role, you will lead cross-functional… more