- Oracle (Denver, CO)
- …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 (Denver, CO)
- …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 (Denver, CO)
- …, 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
- Otsuka America Pharmaceutical Inc. (Denver, CO)
- **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
- University of Colorado (Aurora, CO)
- **Associate Head (Vice Chief) for Clinical Affairs , Division of Cardiology** **Description** **Department: Cardiology** **Job Title:** **Open Rank- Associate ... Professor or Professor -** **Associate Head (Vice Chief) for Clinical Affairs , Division of Cardiology** **Position #: 00840956 - Requisition #:38113** **Job… more
- Fujifilm (Denver, CO)
- …**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
- Cardinal Health (Denver, CO)
- …& 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. (Denver, CO)
- …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
- State of Colorado (Denver, CO)
- …Job Type Full Time Job Number NAA-24000-12.2025 Department Department of Local Affairs Division Division of Housing Opening Date 12/17/2025 Closing Date 12/31/2025 ... residents of the State of Colorado. About the Colorado Department of Local Affairs The Department of Local Affairs (DOLA) (https://cdola.colorado.gov/) serves as… more
- Stryker (Denver, CO)
- …Bachelor's degree * 10+ years of work experience required * 7+ years medical device or marketing/sales experience preferred * Experience developing strategic ... working with Surgeons, KOL or Clinical influencers **Preferred** + 5+ year in sales or medical education in the medical device industry + People leadership… more
- Zimmer Biomet (Englewood, CO)
- …with respect to medical device development. + Understanding of medical device industry regulatory requirements required. + Proficient with CAD. ... design efforts to minimize patient risk and adhere to regulatory requirements + Lead in development of testing protocols...with 6+ years of experience + Prior experience in medical device development required. + Prior experience… more
- Edwards Lifesciences (Denver, CO)
- …+ Knowledge of cardiovascular physiology and structural heart anatomy + Previous medical device Clinical Research experience in cardiology + Clinical research ... patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you… more
- Otsuka America Pharmaceutical Inc. (Denver, CO)
- …Minimum 5 - 7 years of experience in a regulated industry (pharmaceutical or medical device ), with 3-5 years in in pharmaceutical quality, with specific ... or similar. + Certification in DEA compliance, Quality Assurance, or Regulatory Affairs . **Competencies** **Accountability for Results -** Stay focused… more
- Edwards Lifesciences (Denver, CO)
- …patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you ... and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to… more
- Edwards Lifesciences (Denver, CO)
- …assigned studies + Contributing to additional initiatives that shape the future of medical device development **What you'll need (Required):** + Ph.D. or ... patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you… more
- Bluepeak (Denver, CO)
- …providing high-level support to the VP of Legal and the Director of Contracts & Regulatory Affairs . This role manages a broad range of legal and compliance ... corporate and employment law activities, ensuring company compliance with legal and regulatory requirements. + Draft, review, and organize a wide variety of legal… more