- Unknown (Chicago, IL)
- …A minimum of 15-20 years' of healthcare compliance experience in the pharmaceutical or medical device industry is required, along with a deep understanding of ... matters, ensuring that all materials and communications meet legal and regulatory standards, and leading compliance training, auditing, and monitoring programs. This… more
- Oracle (Springfield, IL)
- …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 (Waukegan, IL)
- …+ 1-3 years Regulatory Affairs experience, preferably in the Medical Device industry + Strong proficiency in Microsoft Office Applications preferred + ... Cardinal Health is seeking a Senior Regulatory Affairs Specialist to support the Medical Solutions...provide regulatory support on a range of medical devices . Job responsibilities include support of… more
- Actalent (North Chicago, IL)
- …+ Review and approve manufacturing changes for Class III implantable medical devices . Essential Skills + Regulatory affairs expertise + Experience with ... Job Title: Regulatory Affairs Associate IJob Description The...for this temporary role may include the following: * Medical , dental & vision * Critical Illness, Accident, and… more
- Oracle (Springfield, IL)
- …and industry collaboration around AI in healthcare. Required Qualifications + 8+ years in medical device regulatory affairs or regulatory ... deep regulatory and scientific leadership for AI-enabled medical device solutions. This role sits within...as a reviewer, regulatory scientist, or senior regulatory affairs leader. + Demonstrated experience reviewing… more
- GRAIL (Springfield, IL)
- …, 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
- AbbVie (North Chicago, IL)
- …in close collaboration with cross-functional teams and counterparts in quality systems, regulatory affairs , medical writing, clinical development, clinical ... to other AbbVie office locations in the US. Purpose: Medical Device Safety Physician leads the safety...documented prior to submission of reports, including MDRs, to regulatory authorities. + Provide medical input and… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- **Overview** The Vice President of Regulatory Affairs will serve as the senior-most regulatory leader responsible for envisioning, developing, and executing ... Team Leadership * Lead, mentor, and retain a high-performing Regulatory Affairs team, including Regulatory ...product maintenance, and quality systems. * Partner with Commercial, Medical Affairs , and Quality to support compliant… more
- Otsuka America Pharmaceutical Inc. (Springfield, IL)
- **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
- Abbott (Lake Forest, IL)
- …the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000 ... mothers, female executives, and scientists. **The Opportunity** The **Sr. Regulatory Affairs Manager** hired in this role...that also leads Global New Product Introductions and US Regulatory . We're empowering smarter medical and economic… more
