- Merck (Rahway, NJ)
- …**J** **ob description** This position will be responsible for leading and implementing medical device and combination product design controls for both new ... a culture of operational excellence + Ensure processes align with regulatory requirements for medical device and drug combination products (eg, FDA 21 CFR Part… more
- Sanofi Group (Cambridge, MA)
- …(GRA) Device team is a globally diverse team supporting the medical device , combination product, digital health and in-vitro diagnostic (IVD) products ... strategic partner within Sanofi's regulatory framework, providing expert guidance on medical device regulatory requirements across the product lifecycle. Our… more
- Merck (West Point, PA)
- …their knowledge of product and process development in the (bio)pharmaceutical and/or medical device industries to set tactical and strategic direction on ... development activities including engineering design, engineering analysis and testing, medical device design controls, risk management, test method/fixture… more
- Takeda Pharmaceuticals (Lexington, MA)
- …degree with 15+ years of experience** + Minimum 5 years of combination product, medical device , or pharmaceutical industry experience + Experience with both ... Develop Device Clinical Development Strategy for Combination Products and Medical Devices + Develop comprehensive risk management strategies for devices and… more
- AbbVie (Irvine, CA)
- …CFR Parts 3, 4, GCP, GLP, 210/211, 820 QSR (Design Control), European Medical Device Directives and Regulation (MDR/IVDR), ISO 13485, MDSAP, technical standards, ... that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a...compliance trends to drive proactive initiatives to ensure compliance for Device /Combination Products. + Understanding of… more
- Merck (West Point, PA)
- …Modes and Effects Analysis (FMEA), implementing risk control measures, and performing overall device risk evaluations in compliance with ISO 14971 and other ... team and with external partners. + Understand and apply regulatory and compliance requirements relevant to device risk management activities, ensuring adherence… more
- Kelly Services (Irvine, CA)
- …CA. Johnson & Johnson is rapidly expanding and is immediately hiring qualified Medical Device Assemblers to support production demand and new product ... development. **Position Summary:** As a Medical Device Assembler, you will play a...of new products onto the manufacturing line. + Maintain compliance with GMP, ISO, SOP, and safety guidelines. +… more
- Trinity Health (West Des Moines, IA)
- …meetings, quality improvement initiatives, and continuing education pertinent to cardiac device management. + **Documentation and Compliance :** + Maintain ... **Employment Type:** Full time **Shift:** **Description:** The Cardiac Device Nurse plays a critical role in the comprehensive care of patients with implanted… more
- Edwards Lifesciences (Irvine, CA)
- …proficiency in using applications on iPad + Experience managing clinical trials within medical device industry + Understanding and knowledge of clinical ... patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will… more
- Intermountain Health (Grand Junction, CO)
- …clinical, educational, research and administrative support for the implantable device program. The position coordinates the interrogation of the implantable ... devices which includes device data that is acquired during onsite ...+ Continuous Learning + Attention to Detail + Regulatory Compliance **Minimum Qualifications** + High School Diploma or equivalent… more