- Abbott (Alameda, CA)
- …a high-performing QARA team with deep expertise in software quality , regulatory affairs, and medical device compliance. + **Post-Market Surveillance:** ... Assurance and Compliance system optimized for Software as Medical Device . In addition, this individual will...+ **Global Regulatory Strategy:** Develop and execute regulatory strategies for software-enabled medical devices… more
- AbbVie (North Chicago, IL)
- …projects. Works in close collaboration with cross-functional teams and counterparts in quality systems, regulatory affairs, medical writing, clinical ... to other AbbVie office locations in the US. Purpose: Medical Device Safety Physician leads the safety...documented prior to submission of reports, including MDRs, to regulatory authorities. + Provide medical input and… more
- Sanofi Group (Morristown, NJ)
- …teams + Develop and execute innovative and sustainable medical device regulatory strategies covering stand-alone medical devices and device part ... Sanofi's regulatory framework, providing expert guidance on medical device regulatory requirements across...You'll collaborate across R&D, Device , Manufacturing, and Quality teams while preparing high- quality regulatory… 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
- Veterans Affairs, Veterans Health Administration (Seattle, WA)
- …a critical role in planning, developing, and influencing implementation of quality , regulatory and medical device design projects that support the ... and designers, as well as manufacturing staff to design medical devices . Comprehends clinical approach, clinical datasets...change orders to implement. Maintains an in-depth understanding of medical device regulations, internal quality … more
- Abbott (Maple Grove, MN)
- …Regulatory Affairs departmental responsibilities and processes + Familiarity of medical device regulatory requirements and submission/registration ... be structured under Global Regulatory Services managing projects related to harmonized regulatory processes in Abbott's Medical Device Division. As an… more
- AbbVie (Branchburg, NJ)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description As a Medical Device & Combination Product Quality Intern at ... industry. You will support the Medical Device Combo Product Research and Development Quality ...software, electrical and mechanical components various medical devices and combination products. + Create Quality … more
- Takeda Pharmaceuticals (Lexington, MA)
- …my knowledge. **Job Description** **_OBJECTIVES/PURPOSE_** + Set and execute Takeda's global Quality strategy for medical devices , combination products, in ... the design, implementation, and continuous improvement of operations and quality systems for medical device ...quality standards. + Define and lead the global Quality strategy for medical devices ,… more
- BeOne Medicines (Emeryville, CA)
- **General** **Description:** The Director, Regulatory Affairs, Dx/CDx and Medical Devices will be responsible for leading a small team for developing and ... implementing regulatory diagnostic and medical device ...externally with a solid background in medical devices /diagnostic development regulations and associated regulatory deliverables.… more
- AbbVie (Irvine, CA)
- …globalization of the AbbVie quality management system in support of AbbVie medical devices and combination products. The role serves as Deputy Person ... both current and emerging regulations and standards impacting AbbVie medical device and combination products. + Performs regulatory compliance assessments to… more
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