- ThermoFisher Scientific (Austin, TX)
- …is safe or helping find cures for cancer. **Discover Impactful Work** As a Sr. Manager , Regulatory Affairs, you will play a crucial role in interpreting and ... and communicate the impact of relevant global regulations, guidelines, and evolving regulatory trends relating to pharmaceutical product development in the area… more
- Otsuka America Pharmaceutical Inc. (Austin, TX)
- …drug products and drug-device combination products. Ensure compliance with global regulations ( FDA , EMA, ICH, WHO) and anticipate regulatory changes impacting ... strategies for post-approval changes, line extensions, and global harmonization of product registrations. Monitor and implement regulatory updates impacting… more
- Oracle (Austin, TX)
- **Job Description** This role is dedicated to understanding healthcare regulatory requirements (such as HIPAA, HITRUST, FDA , etc.) and guiding cross-functional ... functions. Excellent communication, documentation, and executive presentation skills. Familiarity with regulatory frameworks (eg, HIPAA, HITRUST, FDA ) and their… more
- Oracle (Austin, TX)
- …our next-generation EHR and AI-enabled medical device platforms. As a Clinical Product Manager (Medical Device Focus), you'll provide clinical insight into ... for Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring… more
- Oracle (Austin, TX)
- …our next-generation EHR and AI-enabled medical device platforms. As a Clinical Product Manager (Medical Device Focus), you'll provide clinical insight into ... for Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring… more
- Otsuka America Pharmaceutical Inc. (Austin, TX)
- The Senior Manager , Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract ... and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized… more
- Abbott (Austin, TX)
- …medicines. Our 114,000 colleagues serve people in more than 160 countries. **Job Title** Product Manager **Working at Abbott** At Abbott, you can do work that ... around the world. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures,… more
- Fujifilm (College Station, TX)
- …an engineering role in a pharma/biotech manufacturing facility or equivalent, preferably regulated by FDA or any other regulatory agency; OR + Master's degree in ... **Position Overview** The Principal Engineering Manager - Reliability Engineering at Fujifilm Biotechnologies Texas...a pharma/biotech manufacturing facility or equivalent, preferably regulated by FDA or any other regulatory agency +… more
- Abbott (Plano, TX)
- …systems (hardware, software, mobile apps, cloud). + Track record of successful product launches requiring MRI safety labeling and regulatory approval. Apply ... **The Opportunity** We are seeking an experienced MRI Safety Engineering Senior Manager to lead our MRI Safety Engineering team within the R&D organization.… more
- Edwards Lifesciences (Austin, TX)
- …+ As a key member of the Medical Affairs Clinical Science team, the Senior Manager (formal internal title is Senior Manager , Medical Affairs) is responsible for ... evaluations for a dynamic portfolio of products across TMTT. The Senior Manager will be an experienced medical device professional with strong scientific acumen… more