- Fresenius Medical Care (Albany, OR)
- …DUTIES AND RESPONSIBILITIES: QUALITY : Responsible for supporting and driving quality standards through meeting regulatory requirements and the practice of ... equipment and technology, including but not limited, patient monitors, defibrillators, medical recording devices and computers. Ensures the inspection of… more
- Belmont Village Green Hills (Nashville, TN)
- …of the community while supporting the Director of Nursing in wellness initiatives, regulatory compliance and quality monitoring. You must be a licensed nurse ... decisions and manage conflict resolution constructively Update and review resident medical records, clinical documentation, and incident reports Assist the Director… more
- Belmont Village Fort Lauderdale (Fort Lauderdale, FL)
- …Belmont Village, you will administer medications, support wellness initiatives, help ensure regulatory compliance and assist with quality monitoring in our ... in a positive and constructive manner Update and review resident medical records, clinical documentation, and incident reports MINIMUM QUALIFICATIONS Active LVN… more
- Fresenius Medical Care (Vicksburg, MS)
- …and technology, including but not limited to C-arm, patient monitors, defibrillators, medical recording devices and computers, and all emergency equipment. EOE, ... Center complies with the requirements of any governmental or regulatory body having jurisdiction in the premises. Assists the... body having jurisdiction in the premises. Assists the Medical Staff to ensure that medical practices… more
- Fresenius Medical Care (Saratoga County, NY)
- …ensuring alignment with those of the region, division, and company. Implements quality goals and action plans to achieve quality standards. Collaborates ... operations leaders, market development, in-center leadership and patient education and quality teams to promote home therapies growth in assigned programs.… more
- Carle Health (Urbana, IL)
- …technologists. Performs radiation therapy treatment planning. Performs QA procedures on all medical radiation devices and radiation safety surveys, which satisfy ... Overview Comprehensive Medical Physicist in Radiation Oncology, Interventional Radiology and...Safety will be responsible for maintaining State and Federal regulatory requirements specific to the practice of radiation therapy… 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
- Actalent (Lake Forest, CA)
- … submission, Regulatory reporting, Test plan, Regulatory compliance, Compliance, Quality engineering, Medical device , Regulatory affairs, CMC, ... development and sustaining activities. - Strong understanding of global medical device regulations (eg, FDA CFR, EU...device regulations (eg, FDA CFR, EU MDR). Skills Regulatory , new product development, quality , 510(k), Project… 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
- Hologic (Newark, DE)
- …structured decision-making processes. + Regulatory & Quality : Solid familiarity with medical device regulatory standards (eg, FDA 21 CFR 820, ISO ... Program Manager, Medical Device Newark, DE, United States...Leadership: Build and guide high-performing project teams-including R&D, engineering, quality , marketing, manufacturing, and regulatory -ensuring alignment with… more
- Takeda Pharmaceuticals (Lexington, MA)
- …+ Drive the design, implementation, and continuous improvement of operations and quality systems for medical device and digital health ... drive innovation and operational excellence and execute Takeda's global Quality strategy for medical devices ,...diagnostics (IVDs), and Software as a Medical Device (SaMD), ensuring compliance with global quality … more
- Oracle (Oklahoma City, OK)
- …Oracle's success and competitiveness in the healthcare and life sciences sector. As a Medical Device Regulatory Affairs Strategist, you will work in ... SaMD in areas such as Regulatory Affairs, Quality Compliance, Product Development, etc. in medical ...Affairs, Quality Compliance, Product Development, etc. in medical device industry or equivalent. Experience authoring… more
- Takeda Pharmaceuticals (Lexington, MA)
- … devices , combination devices , and Software as a Medical Device (SaMD). You will ensure that Quality System requirements are established, effective, ... quality compliance direction and oversight for GxP medical devices , including stand-alone devices ,...and industry interactions. + Partner with critical stakeholders in Regulatory Affairs, Device Quality , and… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …and development of quality engineering team members + Represent Regeneron's medical device QMS during regulatory inspections and partner audits ... We are currently looking to fill a Manager, Medical Device Quality Assurance...in Design Reviews associated with combination products and/ or medical devices + Maintain the quality… more
- Oracle (Augusta, ME)
- …the software architecture and compliance framework for regulated medical devices . This role bridges product development, regulatory , and enterprise ... & Quality Alignment + Ensure adherence to medical device software standards including IEC 62304...Regulatory & Compliance Knowledge + Working knowledge of medical device software standards such as IEC… more
- Gilead Sciences, Inc. (Foster City, CA)
- …in compliance with relevant regulations, standards, and guidelines for medical devices , combination products and diagnostics. + Review device cases / ... **Patient Safety Strategic Operations** team as an **Associate Director, Patient Safety Medical Device Safety** responsible for supporting activities to ensure… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …10 years experience in Quality , Regulatory , or Operations of a Medical Device , IVD, Pharmaceutical or Biotech firm. + Minimum 5 years experience directly ... **Job Description Summary** The Associate Director, Quality Systems & Architecture will be responsible for...Global expectations and between MMS platforms (including Class I/II medical devices and non- medical … more
- AbbVie (North Chicago, IL)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description As a Medical Device & Combination Product Quality Knowledge Management ... industry. You will support the Medical Device Combo Product Research and Development Quality ...working collaboratively and strategically with colleagues in R&D, Operations, Regulatory Affairs, Medical Safety and more to… 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
- 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
