- Regeneron Pharmaceuticals (Tarrytown, NY)
- …advancing its pipeline portfolio using a data-driven human translational approach. The In Vitro Diagnostic (IVD) Regulatory Affairs (RA)Team along with the ... biomarker strategies across its growing clinical portfolio. The Sr. Manager , Regulatory Affairs IVD will...team and key cross-functional stakeholders to deliver novel in vitro diagnostics in support clinical development. **In this role,… more
- ICON Clinical Research (Farmingdale, NY)
- …manage matrix teams and have regulatory project management experience. The role: As a Regulatory Affairs Manager you will need to be experienced with In ... Manager , you will work in Global Regulatory Affairs team, a successful and driven...Vitro Diagnostic (IVD) Medical Device regulation and Laboratory Developed… more
- BD (Becton, Dickinson and Company) (Sparks, MD)
- …**of possible** with us. **About the role:** Reporting to the Director of Regulatory Affairs , responsible and accountable for developing and implementing sound ... and for to cross-functional groups across BD. + Provides recommendations for BDDS Regulatory Affairs functional budget. **About you:** + Ability to think… more
- ThermoFisher Scientific (Austin, TX)
- …**Discover Impactful Work:** The Senior Manager will work in the Regulatory Affairs department and will establish and implement global regulatory ... science required. **Experience:** + Minimum of 7-10 years Regulatory Affairs experience in Pharmaceutical, Biologics, In vitro diagnostics, or Medical… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- …and submissions for Implantable and Absorbable devices. Under the mentorship of the Senior Manager of Regulatory Affairs , they are responsible for the ... **Job Description Summary** The Senior Regulatory Affairs (RA) Specialist within the...of experience. + Three (3) years Regulatory Affairs experience with medical devices or in vitro… 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
- 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
- ManpowerGroup (De Soto, KS)
- …with colleagues from R&D, Biotechnology Solutions-Analytics, Production, Quality Control, and Regulatory Affairs to support qualification of new reference ... testing** work. + **Majority is testing -** formulations of vaccine under manager 's supervision. + Documentation work + Needs to follow good laboratory practices.… 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
- ThermoFisher Scientific (Portage, MI)
- …the US-IDD Quality Manual and required Quality Agreements. May also serve as backup for Regulatory Affairs in the event of absence or workload concerns. This may ... 13485 for the US division of IDD. Interpret, provide counsel, and implement regulatory and quality system requirements. Advise management and personnel in order to… more
- Abbott (Chicago, IL)
- …develops and communicates timelines to manager and collaborates with R&D, Regulatory Affairs , Quality, Clinical Affairs , and Medical Affairs ... currently has an opportunity for the **Section Head, Medical** **Writing** within the Regulatory Affairs Dept. of our Transfusion Medicine Division of Core… more
- L'Oreal USA (Clark, NJ)
- …(in-vivo SPF tests, UVA in- vitro tests), formulation development or regulatory affairs , is preferred. + Strong organizational skills, scientific excellence, ... and/or OTC products) is required. Experience in quality assurance, regulatory affairs , CRO testing, or Pharmaceutical Clinical...week work from home for eligible roles, subject to manager approval) + Flexible Time Off (Paid Company Holidays,… more
- Abbott (Alameda, CA)
- …staff, and clinical management. + Working knowledge of CFR, ICH-GCP, Clinical and Regulatory Affairs + Flexibility in daily activities. + Proficient with ... (GCPs), ICH guidelines, Federal Regulations, department procedures, and other applicable regulatory requirements. + Participate in study start up activities. +… more
- University of Pennsylvania (Philadelphia, PA)
- …management of laboratory tools, documentations, and processes to ensure regulatory compliance and timely completion of project/program deliverables. There will ... as part of a multidisciplinary team and will report to the Research Project Manager C. Job Description Job Responsibilities + Perform in vitro experiments such… more