- Oracle (Albany, NY)
- …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
- Oracle (Albany, NY)
- …driving Oracle's success and competitiveness in the healthcare and life sciences sector. As a Medical Device Regulatory Affairs Strategist, you will work ... To remain competitive in this rapidly changing landscape, organizations require regulatory affairs professionals who can navigate complex and fast-changing… more
- GRAIL (Albany, NY)
- …, 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
- Regeneron Pharmaceuticals (Troy, NY)
- …for the assigned drug/ device portfolio. This role involves overseeing regulatory affairs staff, various outside contractors, supporting project teams and ... Health Authority. **A typical day might include:** + Oversee the assigned CMC/CP Regulatory Affairs team, driving global regulatory strategies and… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- **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 (Albany, NY)
- …**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
- Veterans Affairs, Veterans Health Administration (Syracuse, NY)
- …including, but not limited to, node to server failures. Adheres to VA Medical Device Cyber Security policies and procedures in pre-procurement, during system ... as a purchase card holder, as required. Investigates, remediates and documents Repairable Medical Device recalls and safety alerts issued through the VA Alerts… more
- Mount Sinai Health System (New York, NY)
- …studies + 3+ years of direct experience in Regulatory Affairs , Clinical Affairs or Quality Assurance within the Medical Device Industry Preferred: + ... **Job Description** A Regulatory Compliance Coordinator position is currently available within...medical knowledge preferred. **Responsibilities** + Protocol development: Provides regulatory support to clinical trial project teams. Work with… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …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
- Wolters Kluwer (New York, NY)
- …a pivotal role in driving the development and delivery of Software as a Medical Device (SaMD) products. This position is responsible for enabling engineering ... The Principal SaMD TPM acts as a bridge between engineering, product, regulatory affairs , clinical, and quality assurance teams, facilitating strategic… more
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