- Oracle (Indianapolis, IN)
- …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
- Bausch + Lomb (Indianapolis, IN)
- …+ Minimum of 8 years in recent experience in strategic pharmacuetical Regulatory Affairs . This position does not work with medical device , cosmetics or ... and ability to see the business drivers outside of Regulatory Affairs + Ability to take innovative...**We offer competitive salary & excellent benefits including:** + Medical , Dental, Eye Health, Disability and Life Insurance begins… more
- Fujifilm (Indianapolis, IN)
- …**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
- Lilly (Indianapolis, IN)
- …a global regulatory strategy which supports product (including delivery device and relevant medical devices) development, registration, and lifecycle ... world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs , Global Regulatory Lead...countries for assigned products/programs, bringing in regional, CMC and Device regulatory scientists as needed. + Consistently… more
- Lilly (Indianapolis, IN)
- …a global regulatory strategy which supports product (including delivery device and relevant medical devices) development, registration, and lifecycle ... world. **Purpose:** The purpose of the Senior Director, Global Regulatory Affairs , Global Regulatory Lead...countries for assigned products/programs, bringing in regional, CMC and Device regulatory scientists as needed. + Consistently… more
- Lilly (Indianapolis, IN)
- …as required. + Provide legal counsel on matters related to drug, medical device and diagnostic clinical programs and regulatory submissions in the US and ... also provides regulatory law advice to Global Regulatory Affairs , Manufacturing & Quality, Global Patient...provide legal advice regarding regulations and strategy on drug, medical device (software and hardware) and diagnostic… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …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
- Roche (Indianapolis, IN)
- …Near Patient Care products. In close collaboration with our interfaces in Marketing, R&D, Regulatory Affairs and IT, we ensure that our customers receive the ... in planning completion deadlines and close collaboration with relevant internal interfaces, eg Regulatory Affairs and Marketing + take on the role of Subject… more
- Edwards Lifesciences (Indianapolis, IN)
- …surgery or interventional cardiology are strongly preferred; candidates with other relevant medical device clinical sales support experience will be considered + ... Director and will collaborate with multiple departments including Sales, Clinical Affairs , Marketing, Quality, Regulatory , and Education. After extensive… more
- Lilly (Indianapolis, IN)
- …provide insight into clinical development programs both externally and internally (eg, Medical Affairs , Commercial, CROs, etc.). They will provide clinical / ... academic experience in rare disease, otology, audiology, gene therapy, cellular therapy, and/or medical device a plus + Proven track record of successfully… more
- Danaher Corporation (Indianapolis, IN)
- …to the Senior Manager Manufacturing Quality and is part of the Quality & Regulatory Affairs organization located in Indianapolis, IN. This will be an on-site ... master's degree) in engineering, manufacturing and / or quality systems (ISO 9001), medical device (ISO 13485), pharmaceutical, related life sciences or other… more