- GRAIL (Atlanta, GA)
- …, development, clinical affairs , quality, or program management within the IVD, medical device , or pharmaceutical industries is required. + Regulatory ... FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such...and international regulatory frameworks and processes for medical device development and approvals is required.… more
- Oracle (Atlanta, GA)
- …driving Oracle's success and competitiveness in the healthcare and life sciences sector. As a Medical Device Regulatory Affairs Strategist, you will work ... with SaMD in areas such as Regulatory Affairs , Quality Compliance, Product Development, etc. in medical... Affairs , Quality Compliance, Product Development, etc. in medical device industry or equivalent. Experience authoring… more
- Cardinal Health (Atlanta, GA)
- …in related field or equivalent work experience, preferred + 2+ years' experience in Medical Device Regulatory Affairs /Quality experience preferred + ... **_What Regulatory Affairs contributes to Cardinal Health_**... and product development consulting services to enable pharmaceutical, medical and biotechnology companies to obtain regulatory … more
- Kelly Services (Norcross, GA)
- …MBA) preferred. **Experience:** + Minimum **10 years** of progressive regulatory affairs experience within the ** medical device or biologics industry** ... opportunity in the Norcross, GA area for a Director, Regulatory Affairs (Transfusion).** **Director, Regulatory ...adverse events under **FDA MDR, BPDR** , and **EU/EEA Medical Device Vigilance** systems. + Ensure ongoing… more
- Kelly Services (Norcross, GA)
- …Norcross, GA area for a Principal, Regulatory Affairs (Transfusion).** Principal, Regulatory Affairs - IVD / Medical Devices Location: Norcross, GA ... Regulatory Affairs professional to manage pre-market regulatory activities for medical devices, including in...* Knowledge of FDA 21 CFR 820, Health Canada Medical Device Regulations, MDSAP, and exposure to… more
- Otsuka America Pharmaceutical Inc. (Atlanta, GA)
- **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global ... relationships with other local and/or global functional units [OPC CMC Global Regulatory Affairs , Global Regulatory Strategy, Manufacturing facilities,… more
- Fujifilm (Atlanta, GA)
- …**Job Description** **Responsibilities** + Manage and support the day-to-day legal affairs of assigned Medical Device businesses or ... Counsel and senior business management on general legal and regulatory risks affecting the Medical Device businesses, including with respect to healthcare… more
- Otsuka America Pharmaceutical Inc. (Atlanta, GA)
- …development programs. + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory intelligence needs and ... in a scientific or technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years' work experience in regulatory… more
- Edwards Lifesciences (Atlanta, GA)
- …+ Knowledge and understanding of cardiovascular science + Moderate understanding of medical device regulatory requirements and documents, device ... (RT), Operating Room Technician (ORT), or Cardiovascular Technician (RCIS) or related medical device , clinical, or Certification in RDCS (Registered Diagnostic… more
- Philips (Alpharetta, GA)
- ** Medical Education Program Specialist** You will be responsible for the development, facilitation, execution, documentation, and monitoring of our customer-facing ... Structural Heart Disease (SHD) medical training and educational programs as part of a...forecasting, while maintaining vendor relationships and financial compliance. Uphold regulatory standards and audit readiness for all educational activities,… more
