- Cepheid (Miami, FL)
- …development, specially design control and risk management activities in accordance with FDA and ISO regulations. This position is also responsible to apply ... ensure continued compliance with internal procedures and applicable US FDA , EU IVDR, and other applicable global standards.Fulfill all...device or IVD l industry with applicable knowledge of FDA QSR, EU IVDR and other global regulations ISO… more
- Cepheid (Miami, FL)
- …manner with effective corrective action. Participate in external audit management (eg FDA , ISO, Danaher Corporate, foreign governments), in either a supporting or ... federal regulations and standards including compliance with Food & Drug Administration ( FDA ), ISO 13485, European Union In Vitro Diagnostic Regulation (IVDR) as well… more
- Beckman Coulter Diagnostics (Miami, FL)
- …would be a plus if you also possess:Experience working in FDA -regulated industries or medical device manufacturing environments.Professional certifications such as ... CQE, CQA, Six Sigma, or equivalent credentials in quality or process improvement.Working knowledge of regulatory standards, including ISO 13485, 21 CFR Part 820, and other applicable quality and compliance frameworks.The salary range for this role is $155k -… more
- Aldevron (Miami, FL)
- …test method validation, test method transfer, and method development.Foundational knowledge of FDA , EU, and ICH regulations related to test method validation and ... transfer.Experience with validation of test methods for nucleic acids (mRNA, DNA) and/or protein products.Familiarity with analytical techniques commonly used for nucleic acids and proteins (eg, HPLC, ELISA, capillary electrophoresis (PA800+/BioPhase8800+,… more
- Pall (Miami, FL)
- …ISO 9001 and AS9100 / CAA Part 145/CAA Part 21 standards. GMP, FDA knowledge and other ISO standards an advantage.Good understanding of applicable regulatory ... requirements covering Food Contact, Product Compliance (Ce Marking, ATEX, ASME etc.), Product Environmental Compliance (ROHS/REACH) and airworthiness (CAA/FAA)The salary range for this role is 155,000 - 180,000. This is the range that we in good faith believe… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Compliance Head- US FDA **Location** : Framingham, MA, Morristown, NJ **Job Title:** Compliance Head- US FDA **Location** : Framingham, MA, ... was possible. Ready to get started? **Main Responsibilities:** . **Ensure US FDA GMP Inspection Readiness, Inspection Activities, Inspection Follow-Up** for US … more
- Element Materials Technology (Boulder County, CO)
- …on pulse oximetry, blood pressure monitoring, respiratory health technology, and FDA -regulated medical devices. + **Sales Expansion:** Drive profitable sales growth ... and promote advanced smart health technologies, such as pulse oximeters, FDA -regulated blood pressure monitoring systems, and respiratory rate monitoring devices. +… more
- Bayer (NJ)
- …efficient submissions of high-quality dossiers, driving Food and Drug Administration ( FDA ) communications and negotiations to achieve timely product approvals with ... products, indications or projects, working closely with cross-functional colleagues and the FDA ; + Acts as a critical collaborative partner with the Global… more
- Novo Nordisk (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... to accomplish company goals. External relationships may include interaction with FDA personnel regarding assigned projects and roles. Essential Functions + Compile… more
- Boehringer Ingelheim (Ridgefield, CT)
- …draft CCDS. + Provide US guidance to the global team on FDA submissions, meetings, and pediatric development requirements, including documentation preparation. (3) ... teams during development, registration, and marketing approval considering regulatory precedence and FDA guidance. + Contribute to US RA efforts on draft labeling… more
- Arena Technical Resources, LLC (Rockville, MD)
- …to join our expanding team supporting the US Food and Drug Administration ( FDA ). In this mission-critical role, you will design, implement, and optimize AI and ... machine learning solutions that directly support the FDA 's public health, regulatory, cybersecurity, and operational priorities. This role requires a unique blend of… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …frameworks, Agile SDLC, experience with cross functional team transactions, and various FDA SW related guidance's and industry best practices. The role involves ... and execute comprehensive regulatory strategies for SaMD products in alignment with FDA regulations and guidance documents. + Provide regulatory input during the… more
- BeOne Medicines (San Mateo, CA)
- …The individual will have extensive experience with the United States FDA , oncology division, leading key interactions including supporting advisory committee (ODAC) ... the job:** + Uses extensive knowledge of the US FDA regulatory environment and the ability to apply knowledge...and risk assessments, critical issue management and advice on FDA interactions. + Oversees the preparation of NA regulatory… more
- Zimmer Biomet (Englewood, CO)
- …lead regulatory documentation and submissions, including (but not limited to) US FDA 510(k) premarket notifications, De Novo applications, internal Letters to File, ... regulatory bodies + Review and understand global regulatory requirements ( FDA , TGA, EU MDD, MDR, Health Canada, etc.) +...and mobile health app regulations + In-depth knowledge of FDA guidance on digital health, cybersecurity, and mobile medical… more
- Robert Half Legal (Westhampton, NY)
- …with at least 2 years of experience as an attorney representing FDA -regulated companies in compliance, enforcement, and transactional matters OR experience working ... at the FDA law experience to assist our client with an...practical guidance for topics of interest to attorneys advising FDA -regulated companies including pharmaceutical, medical device, food, dietary supplement,… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …Grifols USA. Generates records to comply with regulatory requirements, (cGMP QSR/ FDA /EN ISO Quality standards, Good Distribution Practices and Internal Quality ... with the rules and regulations of the regulatory agencies ( FDA 21CFR, PIC/s GDP & EN ISO 9001) and...matrixed environment within a pharmaceutical, medical device, GMP or FDA regulated industry. + Must be able to demonstrate… more
- UNC Health Care (Lenoir, NC)
- …judgment and coordinates and supervises the activities to maintain FDA /ACR requirements. **Responsibilities** : + Performs quality radiographs on patients ... supervises all quality control tests to meet ACR and FDA requirements for digital mammography. + Ensures all quality...completed within the required parameters of the ACR and FDA . + Uses appropriate device to measure viewbox intensity.… more
- Kedrion Biopharma (Melville, NY)
- …JOB FUNCTIONS** The Computer Systems Validation Specialist is responsible for implementing FDA 21 CFR Part 11 compliance across automation and computer systems ... History and Audit Trail + Conduct Data Integrity Assessments, FDA 21CFR Part11 and EU GMP Annex11 assessments +...of 2 years of experience in pharmaceutical, biotechnology or FDA regulated industry. + Must have direct experience in… more
- Houston Methodist (Houston, TX)
- …Research Institute Institutional Review Board (IRB), Food and Drug Administration ( FDA ) Code of Federal Regulations (CFR), and the International Conference on ... regulatory team. This position communicates with regulatory affairs office for FDA submissions across multiple studies of different therapeutic areas and phases… more
- Actalent (Hartland, WI)
- …be responsible for teaching how to review documents and comprehend FDA requirements. The position involves verifying details using basic mathematical calculations, ... with equations provided in the batch records. Knowledge of FDA facility document review processes is beneficial, and it is crucial to ensure that the verifier is not… more
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