- 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)
- …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. (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
- BD (Becton, Dickinson and Company) (Louisville, CO)
- **Job Description Summary** The Regulatory Affairs Specialist II is responsible for implementation of strategies including domestic and international submissions ... + Must have knowledge of the US and European medical device regulations + Must have excellent...with software and capital systems is a plus. + Regulatory Affairs Certification (RAC) desired At… 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
- Veterans Affairs, Veterans Health Administration (Grand Junction, CO)
- …and initiates corrective action to address deficiencies. Complies with the facility's medical device protection program. Ensures networked medical equipment ... Technology Management (HTM) department at the facility. Works in support of the medical equipment management program. In addition to duties at the full performance… 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 (CO)
- …Job Type Full Time Job Number NAA-70054-12.2025 Department Department of Local Affairs Division Division of Property Taxation Opening Date 12/11/2025 Closing Date ... 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
- Medtronic (Lafayette, CO)
- … regulatory compliance** - Provides expertise in interpreting and implementing regulatory requirements, including medical device directives, FDA ... **Works with cross-functional teams** - Collaborates with R&D, Operations, Regulatory Affairs , and Clinical teams to provide...tools (FMEA, FTA, PHA, ISO 14971) + Knowledge of medical device regulations: FDA 21 CFR Part… more
- Medtronic (Lafayette, CO)
- …with deep knowledge of ISO 14971 to lead risk management strategy for our medical device products (Capital and disposable). This role is pivotal in ensuring ... + Collaborate with cross-functional teams, including R&D, manufacturing, NPD and regulatory affairs , to define and implement systems engineering processes… more
- Philips (Colorado Springs, CO)
- ** Medical Education Program Specialist** You will be responsible for the development, facilitation, execution, documentation, and monitoring of our customer-facing ... Structural Heart Disease (SHD) medical training and educational programs as part of a...forecasting, while maintaining vendor relationships and financial compliance. Uphold regulatory standards and audit readiness for all educational activities,… more
- Edwards Lifesciences (Denver, CO)
- …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
- Medtronic (Lafayette, CO)
- …stakeholders-including upstream marketing, innovation delivery, R&D, clinical partners, regulatory affairs , and commercial teams-the Global Product ... Experience:** + Proven experience in **product ownership or management** within the ** medical device , diagnostics, healthcare IT, or life sciences** industries.… 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