- Abbott (Maple Grove, MN)
- …managing projects related to harmonized regulatory activities in the Abbott's medical device division. As an individual contributor, the function of a ... medical products, nutritionals). 2-3 years of experience in regulatory preferred but may consider quality assurance,...- Regulatory Review + EU and US medical device compliance + Project management skills… more
- US Tech Solutions (Tewksbury, MA)
- …learn and adapt to new systems. + Customer facing, manufacturing and/or Quality / Regulatory experience in medical device and/or clinical industries. + ... providing front line support for internal and external customers regarding quality and regulatory related inquiries and issues, and act as liaison between… more
- CTG (Woodland, CA)
- …preferred) **Qualifications** * Minimum 3 years' experience in Quality or Regulatory , preferably in medical device , pharmaceutical, or biotechnology ... Quality Engineer II will develop and support all Quality Management System (QMS) and Regulatory Affairs (RA) activities in alignment with site quality … more
- CTG (Tewksbury, MA)
- …learn and adapt to new systems. + Customer facing, manufacturing and/or Quality / Regulatory experience in medical device and/or clinical industries + ... quickly, identify duplicates, assign to relevant functions, identifying and escalating urgent quality and regulatory issues as needed according to QRS guidelines… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …technical field + Minimum of 10 years of experience in Quality or Regulatory function within the medical device industry, including experience with Class ... Collaborates with leadership in Business Unit Quality , Regulatory Affairs, R&D, Operations, Service, Medical Affairs,... Quality Operations, etc.) + Experience in full Medical Device product lifecycle. Ie Demonstrated … more
- Bausch Health (Bothell, WA)
- … required + Must have a solid understanding of Change Management/Life Cycle Management of medical device products along with the impact of changes on US Canada ... written and communication skills. + Should have experience authoring complete 510(k) submissions, Medical Device license applications (Class II or above), EU MDR… more
- J&J Family of Companies (Irvine, CA)
- …study team; o Cooperates with cross-functional teams (Research & Development, Complaint Handling, Quality / Regulatory , Medical Affairs, Medical Safety) to ... R&D partners and cross-functional partners (eg Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and.... Clinical/ medical background is a plus. . Medical device experience is highly preferred. REQUIRED… more
- Jabil (West Chester, PA)
- …communities around the globe. Are you experienced in Medical Device Regulatory Compliance? Jabil is seeking a qualified Quality Systems & Compliance Lead ... , you will manage, as an individual contributor, all Regulatory Compliance activities at the assigned sites. You will...exempt personnel + Knowledge of the US and international medical device quality system regulations,… more
- Integra LifeSciences (Plainsboro, NJ)
- …treatment pathways to advance patient outcomes and set new standards of care. The **Sr.** ** Quality Engineer - Medical Device / Pharma** will provide Plant ... Device Directive, the Canadian Medical Device Regulations (CMDR), and other applicable regulatory ...Experience: 6 to 8 years of experience in a Quality Assurance role for medical device… more
- Takeda Pharmaceuticals (Lexington, MA)
- …+ Develop Device Clinical Development Strategy for Combination Products and Medical Devices + Develop comprehensive risk management strategies for devices ... device , or pharmaceutical industry experience + Experience with both medical devices , drug- device combination products, digital health technologies… more