- DivIHN Integration Inc (Lake Forest, IL)
- …contact one of our Talent Specialist Rashi | 630 8471027 Title: Regulatory Affairs Associate Location: Lake Forest, IL ( Manager prefers position to be onsite ... approvals/licenses/authorizations for existing marketing authorizations. Experience: 4 years' experience in Regulatory Affairs role; Strong knowledge of IVDR and… more
- FISI - FUJIFILM Irvine Scientific (Santa Ana, CA)
- …medical devices and in vitro diagnostic devices. In addition, the Clinical Affairs Program Manager will perform annual activities associated with Post Market ... Overview We are hiring a Clinical Affairs Program Manager . The Clinical ...assessment and product labeling as well as clinical / regulatory strategiesStay current on clinical research and developments as… more
- AbbVie (Chicago, IL)
- …Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Manager , Regulatory Affairs In Vitro Diagnostics and Companion Diagnostics works ... implements, and documents policies and procedures within the regulatory affairs department under supervision of manager . Participates in initiatives internal… more
- 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)
- …one diagnosis at a time. You will be a part of the Immunoassay Regulatory Affairs team and report to the Senior Manager of Regulatory Affairs . ... lives with diagnostic tools that address the world's biggest health challenges! The Regulatory Affairs Analyst II at Beckman Coulter Diagnostics is a… 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
- ThermoFisher Scientific (Cambridge, MA)
- …and influencing capabilities, with demonstrated experiences working with commercial, medical affairs , regulatory , compliance and other internal stakeholders + ... 25 countries worldwide IDD is the global leader in in- vitro allergy testing and the European leader in autoimmunity...Market Access, Value and Evidence Team within Medical Scientific Affairs and will report to the Global Director, Market… more
- Dentsply Sirona (Charlotte, NC)
- …a difference** -by helping improve oral health worldwide. The Clinical Research Manager , Orthodontic Aligner Solutions (OAS) is responsible for the planning and ... clinical investigation documentation to Independent Ethics Committees/Review Boards and Regulatory Authorities + Registration of clinical studies in applicable… 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
