- 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
- Cardinal Health (Indianapolis, IN)
- …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
- GRAIL (Indianapolis, IN)
- …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
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- **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 (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
- Lilly (Indianapolis, IN)
- …include: technical services, manufacturing operations, quality assurance, quality control or regulatory affairs **Additional Preferences:** + Broad knowledge of ... This position is responsible for providing GMP/GxP support across the different regulatory reporting and inspection support that is provided by the RCPMR (… 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
- Cook Medical (Bloomington, IN)
- Overview The Packaging Engineer 2 uses their experienced in medical device packaging to design and develop solutions for new and modified products. This includes ... packaging activities with a cross-functional team including SBU Product Management, Regulatory Affairs , Operations, Quality Assurance, Clinical Affairs ,… more
- Wolters Kluwer (Indianapolis, IN)
- …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
- Cook Medical (Bloomington, IN)
- …function teams including quality, engineering, production, clinical, and regulatory affairs .- Provide leadership in the understanding of medical device ... FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements. Must work and interact effectively and professionally...degree and 5-8 years of experience- Demonstrates knowledge of medical device regulation (ISO 13485, 21CFR) and… more
- Cook Medical (Bloomington, IN)
- …function teams including quality, engineering, production, clinical, and regulatory affairs .* Provide leadership in the understanding of medical device ... Industrial Engineering, * 3-5 years of experience* Demonstrates knowledge of medical device regulation (ISO 13485, 21CFR) and risk management (ISO 14971)*… 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