- J&J Family of Companies (Irvine, CA)
- …Quality & Compliance , Health Economics & Market Access, and Professional Medical Education to influence overall regulatory and commercial strategy, as well ... report for all new products + Account for the medical content of internal product documentation and regulatory...Medical /Clinical/R&D teams in a regulated, commercial biomedical or medical device business is strongly preferred 9.)… more
- Stryker (San Jose, CA)
- … Medical Device (SaMD) and Software in a Medical Device (SiMD), supporting post-market activities to ensure compliance , drive customer quality, and ... Action and Preventative Action (NC/CAPA). Additionally, extensive experience within themedical device industry, ensuring compliance with regulatory standards… 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 + ... + Lead and develop direct report associates to ensure regulatory compliance + Problem solve and escalate...to comply with new and existing regulations (eg, FDA Medical Device Regulations, EU-MDR) + Support the… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …or other technical field + Minimum of 10 years of experience in Quality or Regulatory function within the medical device industry, including experience with ... Unit Quality, Regulatory Affairs, R&D, Operations, Service, Medical Affairs, Legal, Regional Compliance , and Post...(Design Assurance, Quality Operations, etc.) + Experience in full Medical Device product lifecycle. Ie Demonstrated … more
- Stryker (San Jose, CA)
- …skills + Experience with regulatory agencies (FDA, MoH, TUV) and medical device regulations (820, IEC 62304/82304, 60601), with experience in Software ... Assurance** to support our Medical 's Digital Health division and portfolio Software as a Medical Device (SiMD) or Software in a Medical Device (SiMD)… more
- Terumo Neuro (Aliso Viejo, CA)
- …medical device industry to contribute to overall quality and regulatory compliance objectives. Encompass a broad spectrum of responsibilities including ... laws, regulations, standards, good clinical practices, and guidelines applicable to the medical device industry. + Identify gaps and develop and/or standardize… more
- J&J Family of Companies (Santa Clara, CA)
- …Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated ... experience in therapeutic ultrasound research or a PhD (preferred). + Ultrasound based medical device product development is highly preferred. + May serve as… more
- Actalent (Vista, CA)
- …annual reports, control documents, etc. to FDA authorities. + File Vigilance Reports or Medical Device Reports to Competent Authority or FDA. + Review ... Specialist is primarily responsible for overseeing the quality and regulatory aspects of the company. This includes the development...+ Quality Management System (QMS) + Quality assurance + Medical device auditing + CAPA (Corrective and… more
- AbbVie (Irvine, CA)
- …*Supplier oversight, assuring responsible Third Parties are complaint with cGMPs, regulatory and corporate compliance requirements and contractual agreements as ... that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a...related products. + Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device… more
- Kelly Services (Irvine, CA)
- …an_ **_R&D Engineer_** _for a long-term contract at one of our_ **_Global Medical Device_** _clients, located in_ **_Irvine, CA_** _._ _Our Client is a_ **_global ... _As a Kelly employee, you will be eligible for Medical & Dental 50%_ **_paid_** _, 401K and a...and testing according to established policies, procedures, government and compliance regulations, and customer requirements_ + _Build prototypes and… more