- 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
- Medtronic (Lafayette, CO)
- …Have: Minimum Requirements** + Bachelors degree with 4+ years of regulatory affairs experience in the medical device , biotech or pharmaceutical industry ... OR a Masters degree with 2+ years of regulatory affairs experience in the medical device , biotech or pharmaceutical industry. **Nice to Have** +… more
- Bausch + Lomb (Denver, CO)
- …+ 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
- 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
- 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
- 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)
- …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
- Zimmer Biomet (Englewood, CO)
- … device from ideation to commercialization required. * Understanding of medical device industry regulatory requirements preferred. * Experience with ... inspection plans * Aide in publication efforts with Clinical Affairs team * Observe surgery (live, cadaver, or video)...engineering discipline with 3-7 years of development experience in medical device . * Prior experience in taking… 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