- 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
- Danaher Corporation (Chaska, MN)
- …and applicable submissions or registrations. This position is in the Immunoassay Regulatory Affairs team and reports to the Manager of Regulatory ... lives with diagnostic tools that address the world's biggest health challenges! The Regulatory Affairs Analyst II for Beckman Coulter Diagnostics is an… 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