- Beckman Coulter Diagnostics (Miami, FL)
- …regulations and standards including compliance with Food & Drug Administration ( FDA ), Medical Device Single Audit Program (MDSAP), ISO13485, European Union Medical ... preparation and submission of audit responses and requests for information to FDA , MDSAP Notified Body and other Regulatory Bodies.Utilize Danaher Business System… more
- Cytiva (Miami, FL)
- …and improve process performance ensuring compliance with regulatory requirements (eg, FDA , ISO, PSM) and contribute to audits and inspections as necessary.Who ... device production.2+ years experience with regulatory standards and quality systems (eg, FDA , ISO 13485, Good Manufacturing Practices - GMP).2+ years experience with… more
- Cytiva (Miami, FL)
- …Operations within Life Sciences, Biotechnology, Medical Device, Biopharma, or other FDA or EPA-regulated manufacturing environments.Possess a minimum of 4 years of ... preferred.Regulatory and Quality Expertise: Strong knowledge of ISO standards, FDA regulations, cGMPs, CFR requirements, and quality management practices, including… 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
- Aldevron (Fargo, ND)
- …through publications or previous experience.Regulatory Knowledge: Strong understanding of FDA , EU, and ICH regulations related to test method validation, ... transfer, and development.Experience with Nucleic Acids and Proteins: Hands-on experience in validating test methods for nucleic acids (mRNA, DNA) and/or protein products.Analytical Techniques: Proficiency in analytical techniques such as HPLC, ELISA,… more
- Aldevron (Miami, FL)
- …in a development through commercial application, requiredStrong knowledge foundation of FDA and EU regulations regarding the manufacture of biologics (210, 211, ... and 610 CFR and EudraLex Vol. 4), including regulatory inspection or support experience, preferredAbility to manage priorities, track progress of key projects, and provide updates to leadership as required.It would be a plus if you also possess previous… more
- Beckman Coulter Diagnostics (Miami, FL)
- …test method, equipment, process, and/or design testing methodologies.Knowledge of FDA regulations, ISO standards, and GxP guidelines.Experience with Computer System ... Validation (CSV) and process validationIt would be a plus if you also possess previous experience in: Experience in IVD Medical device or Pharmaceutical ManufacturingASQ CertificationThe salary range for this role is 100K-115K. This is the range that we in… more
- Aldevron (Miami, FL)
- …Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).Strong foundational knowledge in FDA and EU regulations specific to labels and labeling such as ... 21 CFR Part 210, 211, 610, EU Annex 13, EudraLex Vol 4, ICH Q7, ICH Q9, ICH Q10, and international guidelines#LI-GC1#LI-OnsiteJoin our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with… more
- Aldevron (Miami, FL)
- …experience.Exposure to regulatory agency inspections or other types of audits (eg, FDA , notified bodies, ISO, etc.).Current or past Quality certifications a plus (eg ... ISO 9001, ASQ, etc.)Strong EQPreferred QualificationsExperience in cell and therapy or biological manufacturing is a plusExperience in cell and therapy or biological manufacturing is a plus#LI-GC1#LI-OnsiteJoin our winning team today. Together, we'll… more
- Aldevron (Fargo, ND)
- …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
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