- Vanderbilt University Medical Center (Nashville, TN)
- …. The VUMC Laboratory Quality Management Department is in need of an FDA Regulatory Affairs Manager to join the team! **This position is eligible for ... Administration **Job Summary:** Leads VML's responses to the recent FDA LDT regulations. Develops a team to support our...goals and objectives. Continuously demonstrates a strong focus on quality in spite of time and other pressures. Anticipates… more
- Medtronic (Washington, DC)
- …Corporate and Operating Unit Legal, Global Operations and Supply Chain, Quality , Regulatory, Environmental, Health and Safety, Transportation, Dangerous Goods and ... materials. + Conducting and/or providing legal support to colleagues on compliance investigations that include allegations related to environmental, health and… more
- Amneal Pharmaceuticals (Brookhaven, NY)
- …establishing new, revising and maintaining Global Quality Standards current. The Manager , Regulatory Compliance has direct interface with Site Quality ... Description: The Manager , Regulatory Compliance , assembles a team...Functions: + Will be the contact person for the FDA and other regulatory agencies in regard to Field… more
- Integra LifeSciences (Plainsboro, NJ)
- …pathways to advance patient outcomes and set new standards of care. This **Senior Manager , Quality Compliance ** will manage and provide oversight on ... Quality Compliance for change control projects and daily operations which...in accordance to the requirements of overall corporate policies, FDA regulations, ISO 9001, ISO 13485, the medical device… more
- Abbott (Pleasanton, CA)
- …allowing people to restore their health and get on with their lives. As a Senior Quality Compliance Manager , the individual will play a crucial role within ... Heart Failure organization with primary focus to maintain overall Quality Management System compliance to internal policies,...sources and proactively address regulatory, compliance , and quality issues. + Actively participate in FDA … more
- Amentum (Groton, CT)
- …and a drive for success, Amentum is looking for you! We are seeking a Quality Compliance Manager for our client US Portfolio. The successful candidate ... may be required based on business demand. As a Quality Compliance Manager , you will...+ Understanding of relevant regulations and industry standards (eg, FDA , ISO, GxP) + Strong analytical and problem-solving skills… more
- Kelly Services (Allerton, IA)
- ** Quality Compliance Manager -** Allerton, Iowa The Quality Compliance Manager will be responsible for establishing, maintaining, planning, ... programs, procedures, and processes required for manufacturing food ingredients in compliance with local, state, and national regulatory agencies. This role ensures… more
- Golden State Foods (Conyers, GA)
- …new standardization initiatives and completes FSQR improvement projects. Coordinates GSF LPNA Quality , Food Safety and regulatory compliance activities to meet ... science, food microbiology preferred. Experience:10 years of relevant food safety & quality programs management work experience in an FDA regulated environment.… more
- Integra LifeSciences (Cincinnati, OH)
- …to advance patient outcomes and set new standards of care. **Summary Description** The Manager , Quality Compliance will have a key leadership role ensuring ... of CAPA Review Board (CRB). + Management of site Training Program to ensure compliance . + Quality Management Review coordination and preparation. + Quality … more
- Catalent Pharma Solutions (Harmans, MD)
- The **Senior Manager , Quality Assurance Data Integrity Compliance ** performs evaluation of internal controls, communications, risk assessments and ... maintenance of documentation as related to compliance with internal and external safety, quality ,...Part 11 instrumentation compliance . + Knowledgeable in Quality Management Systems ( FDA or ICH approach… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- **Job Description Summary** As the Audit Program Manager , you will manage Quality Audit Programs including development, scheduling, and implementing plans for ... **R** **esponsibilities:** + Coordinate and conduct routine and focused quality system audits as assigned to assess compliance... Quality Auditor/ISO Lead Auditor Certified + Certified Quality Engineer + Certified Manager of … more
- Olympus Corporation of the Americas (San Francisco, CA)
- …If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || ... outside US. The Manager , Sr. Global MDR Submission communicates with the FDA or other interested internal and external parties as needed. This position will also… more
- Medtronic (Los Angeles, CA)
- …of the function. + Training and coaching cross-functional peers on maintaining compliance to internal and external Quality requirements and regulations in ... Have** + Experience working in a regulated industry (eg, FDA -regulated) + Master's Degree in Engineering, Quality ,...and work with development and supply vendors to ensure compliance to Medtronic requirements. + FDA regulatory… more
- Abbott (Altavista, VA)
- …manufacturing and distribution of product produced at the plant. + The Plant QA Compliance Manager must be both aggressive and creative in solving problems to ... functional areas of the plant comply with all GMPS, FDA regulations and other practices outlined by federal statutes...evaluate new or changed equipment or processes and resolve quality problems. In compliance with federal law,… more
- Terumo Medical Corporation (Somerset, NJ)
- … Quality Systems & Compliance **Job Summary** The Senior Quality Compliance Engineer will work with the Senior Manager of Quality Compliance ... and revised external regulations and standards. + Partner with Quality Compliance Process Manager to...FDA , ISO 13485, EU MDR, MDSAP and global quality system requirements, preferably for medical devices. + Solid… more
- Integra LifeSciences (Princeton, NJ)
- …organization. The CMP Program Manager will be working alongside the VP, Quality Compliance to provide tactical and strategic oversight of the CMP program, ... CMP efforts across multiple functions, such as manufacturing, regulatory, R&D, and quality assurance, ensuring full compliance and readiness for regulatory… more
- Catalent Pharma Solutions (Somerset, NJ)
- **Position Summary:** Catalent Pharma Solutions in Somerset, NJ is hiring a Senior Manager , Quality Management Systems for the Quality Assurance department. ... the Training Department at the Somerset site. The Senior Manager , Quality Management Systems must possess expert...+ Lead audits of Catalent Somerset site to ensure compliance with foreign and FDA cGMPs, Corporate,… more
- University of Michigan (Ann Arbor, MI)
- HLD & Regulatory Compliance Manager Apply Now **Job Summary** The High-Level Disinfection (HLD) and Regulatory Compliance Manager oversees fiscal and ... employer. **Job Detail** **Job Opening ID** 256715 **Working Title** HLD & Regulatory Compliance Manager **Job Title** Admin Manager Inter Healthcare **Work… more
- Abbott (Des Plaines, IL)
- …maintaining compliance to, and driving continuous improvement of, related quality assurance programs, policies, process, procedures and controls. + Manage the ... education and work experience + Minimum **5 years Related to supplied product quality within an FDA /ISO certified environment.** + Multi-tasks, prioritizes and… more
- Katmai (Brilliant, OH)
- Position is responsible for the implementation, monitoring and maintenance of the Quality System in accordance with FDA Medical Device and Drug regulations. ... procedures, such as the Quality Manual and Quality System Procedures. + Ensure compliance with...and Documentation Control. + Prepare documentation and systems for compliance with the FDA requirements. + Conduct… more
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