- 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)
- …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
- Otsuka America Pharmaceutical Inc. (Atlanta, GA)
- …Minimum 5 - 7 years of experience in a regulated industry (pharmaceutical or medical device ), with 3-5 years in pharmaceutical quality, with specific experience ... TrackWise, or similar. + Certification in DEA compliance, Quality Assurance, or Regulatory Affairs . **Disclaimer** This job description is intended to describe… more
- Edwards Lifesciences (Atlanta, GA)
- …clarity and diplomacy. + Collaboration **:** Partner with sales, clinical, marketing, and medical affairs teams to ensure integrated messaging and execution. + ... Master's Degree or equivalent with 6 years of related experience working in medical device , healthcare or cardiovascular space. + Proven successful project… more
- Edwards Lifesciences (Atlanta, GA)
- …assigned studies + Contributing to additional initiatives that shape the future of medical device development **What you'll need (Required):** + Ph.D. or ... patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you… more
- Quality Consulting Group (Atlanta, GA)
- …roadmaps that support differentiated claims and value messaging. + Partner with Clinical, Medical Affairs , and Market Access to align data generation with ... marketing and regulatory needs. + Translate clinical and economic data into...+ Minimum of 3-5 years of relevant experience. + Software/ Medical device product marketing experience + Social… more
