- Novo Nordisk Inc. (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... and disseminate critical CMR training documentation Ensures training and compliance to FDA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical… more
- Lundbeck (Tucson, AZ)
- …and regulatory environment, including Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. ... healthcare economy and industry practices. Accountability and adherence to corporate, FDA , and PDMA guidelines.REQUIRED EDUCATION, EXPERIENCE and SKILLS: Bachelor of… more
- Aequor (Thousand Oaks, CA)
- …Device Standards Ability to converse technically with mechanical, electronic, software , and quality engineers Previous experience managing implementation of Quality ... Management System Requirements, Product Standards / Regulatory Requirements (eg FDA CFRs for Biologics and Medical Devices, FDA Combination Product Regulation,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... Data Science & Evidence (CDSE) department develops clinical and medical informatics software and system development with customers in collaboration with the research… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …activities for BAS, EMS and other automation and controls system software , hardware and associated interfaces inclusive of data management, issues, deviations, ... that the candidate have deep knowledge of Honeywell and Siemens BAS software , hardware, protocols and IT infrastructure (HC900s, CPO, PXCMs, EBI, Desigo, BACnet,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …as appropriate to maintain the BMS system throughout the component and software lifecycle Provide input during regulatory inspections of BMS and relevant projects ... experience preferred Three (3) years of experience with Siemens Apogee software and system administration preferred Knowledge, Skills, and Abilities: Instrumentation… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …switches and databases. Job Responsibilities:Perform system administration (access control, software revision control, back-up and recovery), and troubleshooting for ... new systemsResponsible for reviewing functional specifications for both hardware and software for new automated utility, process, filling, and packaging and… more
- Aequor (Cincinnati, OH)
- …protocol drafting and execution; periodic reviews experience a plus Familiar with FDA requirements and cGMP guidelines Proficient in MS Office Proficient in ... Industrial Controls application software (Siemens PXCM, VPAK, Siemens Desigo) Attention to detail is essential with the ability to manage multiple projects… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …industry, automotive industry, or similar rigorous production. Strong understanding of FDA regulations is a plus but not requiredProven experience in process ... skills.Ability to analyze data and make informed decisions.Proficient in plant management software and Microsoft Office Suite, SAP is a plus.Ability to comply with… more
- Lundbeck (Minneapolis, MN)
- …accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.REQUIRED ... customer influence network Must be computer literate with proficiency in Microsoft Office software Must live within 40 miles of territory boundaries Driving is an… more
- Lundbeck (Fargo, ND)
- …accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.REQUIRED ... communication skills Must be computer literate with proficiency in Microsoft Office software Must live within 40 miles of territory boundaries Driving is an… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... accuracy review with strong attention to detail. Proficiency in Microsoft Office software applications such as PowerPoint, Excel and Word and overall computer skills… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …other applicable acceptance criteria.Responsible for managing data integrity via software controls (Deskman, Windows, etc).Executes, owns, assesses and participates ... of GMP data integrity standards.Knowledge of cGMP regulations and FDA /EU guidance related to manufacturing of cell-based products.Strong interpersonal and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... serve as a subject matter expect on clinical and medical informatics software and system development with customers in collaboration with the research partnerships… more
- Abbott (Alameda, CA)
- … or embedded firmware under a disciplined product development process that meets FDA requirements. # software **What you'll work on** + Participate in the ... as assigned by management. + Implement approved Design Control procedures for software development in accordance with FDA guidelines. **Required Qualifications**… more
- Abbott (Alameda, CA)
- …or embedded firmware under a disciplined product development process that meets FDA requirements. \# software **What** **you'll** **work on** + Works ... products that meet budgetary objectives. + Implement approved Design Control procedures for software development in accordance with FDA guidelines. + Lead … more
- Abbott (Alameda, CA)
- …or embedded firmware under a disciplined product development process that meets FDA requirements. \# software **What** **you'll** **work on** + Works ... products that meet budgetary objectives. + Implement approved Design Control procedures for software development in accordance with FDA guidelines. + Lead … more
- Abbott (Pleasanton, CA)
- …reporting systems (eg, JIRA). + Experience with FMEA/risk management. + Knowledge of FDA regulations and software guidance, IEC 62304, IEEE 1012, ISO 13485, ... people in more than 160 countries. **Job Title** **Senior Quality Engineer, Software ** **About Abbott** Abbott is a global healthcare leader, creating breakthrough… more
- Bayer (Indianola, PA)
- …IEC62304.ISO14971, FDA 21 CFR part 820.30; + Familiarity with Software Development Lifecycle processes, including Waterfall and Agile methodologies; + Technical ... software in a regulated environment while adhering to FDA Design Controls and software process guidelines for medical devices including ISO 13485 and IEC… more
- Actalent (Carlsbad, CA)
- … of Unknown Provenance (SOUP) tools or packages are up to date. * Own software related FDA 510(k) submission documents * Participate in the design and review ... up to date with industry trends and best practices. Skills Medical device, FDA Compliance, risk management, software quality management, design control, FDA… more
