- GRAIL (Austin, TX)
- …management within the IVD, medical device , or pharmaceutical industries. + Regulatory affairs and IVD device experience preferred. + An advanced ... 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. + Effective… more
- Oracle (Austin, TX)
- …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 (Austin, TX)
- …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
- Otsuka America Pharmaceutical Inc. (Austin, TX)
- **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
- ThermoFisher Scientific (Austin, TX)
- …or helping find cures for cancer. **Discover Impactful Work** As a Sr. Manager, Regulatory Affairs , you will play a crucial role in interpreting and ... requirements and desired marketing claims. + Author and/or review regulatory submissions, specifically device master files, ...count on, which includes: + A choice of national medical and dental plans, and a national vision plan,… more
- Danaher Corporation (Austin, TX)
- … medical technology, medical device , or pharmaceutical industry in Medical or Clinical Affairs roles + Experience leading teams of high performing ... (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Director, Regional Medical Affairs is our Medical &… more
- Danaher Corporation (Austin, TX)
- …the medical technology, medical device , or pharmaceutical industry in Medical or Clinical Affairs roles + MBA or Masters degree in business related ... vital role that requires a blend of strategic understanding and expertise in Medical Affairs /Clinical Affairs to foster advancements in cardiometabolic… more
- Danaher Corporation (Austin, TX)
- …the medical technology, medical device , or pharmaceutical industry in Medical or Clinical Affairs roles + MBA or Masters degree in business related ... about the Danaher Business System which makes everything possible.The Senior Director, Medical & Scientific Affairs - Neurodegenerative Disease is responsible… more
- Edwards Lifesciences (Austin, TX)
- …the ground up. **How you'll make an impact:** + 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 providing scientific...across TMTT. The Senior Manager will be an experienced medical device professional with strong scientific acumen… more
- Cardinal Health (Austin, TX)
- …& Filing + Quality Review Standards + Drug, Biologic (IV, Injectable) and Medical Device Development + Regulatory Outsourcing + Pharmaceutical Compliance ... provided expertise and guidance to help pharmaceutical, biotechnology and medical device companies get their products to...+ Global Regulatory Strategy Development + Global Regulatory Affairs + Chemistry Manufacturing and Controls… more
- Otsuka America Pharmaceutical Inc. (Austin, TX)
- …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
- Danaher Corporation (Austin, TX)
- …global/regional marketing, sales, clinical affairs , quality and regulatory affairs . This position reports to the Chief Medical Officer and is ... medical technology, medical device , or pharmaceutical industry in Medical or Clinical Affairs roles + Experience leading teams of high performing… more
- Edwards Lifesciences (Austin, TX)
- …Knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical ... patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you… more
- Abbott (Austin, TX)
- …field such as public health or health economics. + Five years of Medical Device company experience or relevant systems experience in a hospital/university ... Healthcare Economics, Clinical Operations, Clinical Data Science and Analytics, Marketing, Regulatory , Legal, Clinical Affairs , Research and senior management to… more
- Danaher Corporation (Austin, TX)
- …Qualifications + Experience in the diagnostic/IVD industry. + Experience in the medical device industry. + Experience with healthcare regulation, including fraud ... manufacturing, EH&S, real estate, etc.) + Compliance and Enablement (QRA/MAPSS, clinical affairs , etc.) + Strategy and Business Development (LBS and DHR/DHR Dx… more
