- Gilead Sciences, Inc. (Foster City, CA)
- …and review/approve Gilead and CMO APQRs for commercial products. + Accountable for medical device / combination product quality compliance: engage/liaise with ... medical device product engineering, development, and quality teams. + Facilitate Analytical Strategy (stability strategy, specifications, Critical Quality… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …Files, etc.) + Develop and implement global regulatory strategy for MMS Dispensing Medical Device and non- Medical device products and software + ... to comply with new and existing regulations (eg, FDA Medical Device Regulations, EU-MDR) + Support the...preferred + Minimum of 10 years of directly related Regulatory Affairs experience in medical devices… more
- Abbott (Sylmar, CA)
- …the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000 ... skills, including statistical/data analysis and report writing skills. + Prior medical device experience preferred. + Experience implementing various product… more
- Abbott (Pleasanton, CA)
- …the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000 ... are seeking an experienced, high caliber Senior Supplier Development Quality Engineer to be responsible to act as the...issues in a timely and effective manner + Prior medical device experience preferred + Experience implementing… more
- Abbott (Alameda, CA)
- …the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000 ... development is required. **Preferred Qualifications** + Solid knowledge of regulations for medical device development, (EN460001, ISO13485, FDA) is desirable. +… more
- Stryker (San Jose, CA)
- …Reports (CERs) and post market clinical follow-up (PMCF) documents for new medical devices to support product registrations internationally, maintain periodic ... required CERs, and annual updates. + Performs systematic literature reviews for medical device groups or sub-groups. Interprets literature information and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …factors, design controls, and risk management regulations, standards, and guidance for medical devices and combination products. + Excellentverbal, written, and ... organization. Qualified candidates will focus on the development of devices and drug- device combination products such as...required. + Demonstrated ability to facilitate the interface with medical device vendors and HF consulting firms.… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …management requirements throughout all phases of the life cycle of BD's dispensing medical devices and solutions. They will lead cross-functional teams during ... includes, but is not limited to, risks associated with medical devices such as data integrity, systems...and document decisions and actions taken, aligned with BD's quality systems and ensuring compliance with regulatory … more
- Hologic (San Diego, CA)
- …experience in a regulated environment, ideally in the IVD space. + Working knowledge of Quality Management System for Medical Device Manufacturing FDA 21 CFR ... as well as CE mark requirements, In Vitro Diagnostic Regulation (EU) 2017/746 and Medical Device Regulation (EU) 2017/745, Risk Management ISO 14971, and other… more
- Caldera Medical (Westlake Village, CA)
- …including medical device reporting (MDR) or equivalent regulatory submissions. * Collaborate with cross-functional teams ( Quality , Engineering, ... to ensure compliance with FDA, ISO, and other applicable regulatory requirements. The ideal candidate will have strong analytical...Medical is a growth stage medical device company dedicated to improving the quality … more
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