- JENAVALVE TECHNOLOGY INC (Irvine, CA)
- …customer service team committed to delivering exceptional support to healthcare providers and medical device customers. In this role, you will oversee daily ... with FDA regulations, ISO standards, and quality system requirements applicable to medical devices . Maintain accurate records and participate in internal and… more
- JENAVALVE TECHNOLOGY INC (Irvine, CA)
- …2+ year of experience in clinical trial research is required (preferred in medical devices ). Advanced degree in a biological science / pharmacy/ nursing ... knowledge of GCPs governing the conduct of clinical trials; working knowledge of Medical Device Directive 93/42/EEC, ISO14155 and ICH guidelines. Very organized… more
- Tools for Humanity (San Francisco, CA)
- …supporting the Worldcoin open-source protocol by managing Tools for Humanity's legal affairs globally. We collaborate across the company to advance the blockchain ... and enhance our products, including the Orb (our hardware device ), World ID, World App, and World Chain. We...with the Worldcoin Foundation and other partners to ensure regulatory compliance in areas such as securities, AML/CFT, consumer… more
- Programmable Medicine Operatin (Redwood City, CA)
- …meetings with Clinical Operations, Clinical, Clinical Supply Chian, Quality Assurance, and Regulatory Affairs Responsible for drug substance and drug product and ... on developing novel nanomedicines, HD therapeutics (HDTs), to treat unmet medical needs in ophthalmology, neurology, inflammatory diseases, and neuro-oncology. Our… more
- Meta (Burlingame, CA)
- …a scientific discipline or equivalent work experience 6. 3+ years of industry experience in medical device regulatory affairs or related industry 7. ... regulatory affairs specialist to join our medical devices compliance team. You will get...get to work on wearables and Software as a Medical Device (SaMD) applications for the US… more
- Abbott (Santa Clara, CA)
- …executives, and scientists. **The Opportunity** We currently have several opportunities for the ** Medical Device Regulatory Affairs Development (RAD) ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… more
- Medtronic (Irvine, CA)
- …Medical Device Experience:** Minimum of 4 years of relevant experience in medical device regulatory affairs . + **510(k) Submission Experience:** ... or university required; advanced degree with a minimum of 2 years of experience in medical device regulatory affairs is a plus. + ** Regulatory … more
- Stryker (Fremont, CA)
- …with a solid understanding of regulatory standards and practices. + Exposure to Medical Device Regulatory Affairs or Engineering through coursework, ... Fremont, CA or Salt Lake City, Utah as a Regulatory Affairs Specialist.** At Stryker, we're driven...experience working with US Class II and Class III medical devices . + Demonstrates strong analytical and… more
- J&J Family of Companies (Irvine, CA)
- …Devices sector within **Johnson & Johnson** , is recruiting for an intern for its ** Medical Devices Regulatory Affairs organization** . At **Johnson & ... develop the skills needed to succeed in a global organization. The Intern - ** Medical Devices Regulatory Affairs (MD RA)** opportunity will help you grow… more
- Abbott (Alameda, CA)
- …+ 5 years' experience working with Class II, Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) is a plus. ... medical device regulations and submissions. + Familiar with relevant regulatory requirements for medical devices , drugs and/or biologics including… more
- Abbott (Alameda, CA)
- …. 5 years' experience working with Class II, Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) is a plus. ... regulatory submissions for Pharmaceutical, in vitro diagnostic devices and/or medical devices . ....device regulations and submissions. . Familiar with relevant regulatory requirements for medical devices … more
- Terumo Neuro (Aliso Viejo, CA)
- …assigned clinical reports, documents and scientific presentations in cooperation with the Clinical, Medical , & Regulatory Affairs Teams, KOLs and physician ... a difference in people's lives every day? We're a medical devices company that develops innovative neuroendovascular...a medical writer for pharmaceutical, CRO, or medical device clients). 4. Excellent writing and… more
- J&J Family of Companies (Irvine, CA)
- …all relevant Clinical R&D partners and cross-functional partners (eg Global Strategic Marketing, Medical Affairs , Regulatory Affairs , Health Economics ... based on study need; + In EMEA, responsible for Regulatory Affairs related tasks associated with clinical...with budget planning, tracking and control is required. + Medical Device experience is required. + Sound… more
- AbbVie (Irvine, CA)
- …to be a team leader and engage key stakeholders, including global strategic marketing, medical affairs , regulatory affairs , clinical development, and ... be to evaluate the interaction of current and future medical devices with cells and tissues for...methods to support development of novel medical device /tissue products. + Critically evaluate scientific or regulatory… more
- J&J Family of Companies (Irvine, CA)
- …all relevant Clinical R&D partners and cross-functional partners (eg Global Strategic Marketing, Medical Affairs , Regulatory Affairs , Health Economics ... may include; CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV). + Medical device experience highly preferred. + CRO experience and site management and… more
- Medtronic (Los Angeles, CA)
- …healthcare, or regulatory -related field and 4+ years of regulatory affairs experience, preferably with medical device submissions, registrations or ... device industry, particularly with Class III/II medical devices for both FDA and EU...-related field and 2+ years of regulatory affairs experience, preferably with medical device… more
- Abbott (Alameda, CA)
- …+ Experienced in regulatory submissions for Pharmaceutical, in vitro diagnostic devices and/or medical devices . + Experience of working within ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… more
- Caldera Medical (Westlake Village, CA)
- …Sciences, Biomedical Engineering, or a related field. * 5-7 years of regulatory affairs experience in the medical device industry. * Strong understanding ... Sr. Regulatory Affairs Specialist 100% ONSITE in... Regulatory specialist, you will develop and implement medical device regulatory strategies to… more
- Medtronic (Los Angeles, CA)
- …healthcare, or regulatory -related field and 4+ years of regulatory affairs experience, preferably with medical device submissions, registrations or ... -related field and 2+ years of regulatory affairs experience, preferably with medical device...devices . + 4+ years of US and EU regulatory submission experience (preferred 510(k) and Technical Documentation) +… more
- Abbott (Alameda, CA)
- …+ Work closely with in-country regulatory representatives, compile, prepare, and review medical device or IVD submissions to regulatory agencies in the ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… more
