- Cytiva (Miami, FL)
- …to increase production capacity and improve process performance ensuring compliance with regulatory requirements (eg, FDA , ISO, PSM) and contribute to audits ... preferably in healthcare manufacturing or medical device production.2+ years experience with regulatory standards and quality systems (eg, FDA , ISO 13485, Good… more
- Pall (Miami, FL)
- …System which makes everything possible.Director Global Quality and Regulatory ComplianceJOB SUMMARYInterprets federal/state/international regulations as they apply ... of regulations, devises strategies for compliance, and liaison with regulatory bodies. Investigates and resolves compliance problems, questions and complaints.… more
- Beckman Coulter Diagnostics (Miami, FL)
- …the preparation and submission of audit responses and requests for information to FDA , MDSAP Notified Body and other Regulatory Bodies.Utilize Danaher Business ... regulations and standards including compliance with Food & Drug Administration ( FDA ), Medical Device Single Audit Program (MDSAP), ISO13485, European Union Medical… more
- Cytiva (Pensacola, FL)
- …site's Quality Management Representative, leading QA/QC functions, ensuring regulatory compliance, and aligning with organizational quality goals.Quality Management ... Operations within Life Sciences, Biotechnology, Medical Device, Biopharma, or other FDA or EPA-regulated manufacturing environments.Possess a minimum of 4 years of… more
- Aldevron (Miami, FL)
- …and procedures and collaborating with cross-functional teams, including Clients, Regulatory Affairs, and Marketing, to develop labeling strategies that align ... with regulatory requirements and company branding.In this role, you will...(cGMP) and Good Documentation Practices (GDP).Strong foundational knowledge in FDA and EU regulations specific to labels and labeling… more
- Aldevron (Miami, FL)
- …Quality and release processes in compliance with all foreign and domestic regulatory and statutory requirements. This individual will help to provide the strategic ... as the site's primary contact with both customers and regulatory agencies regarding quality/compliance issues and Negotiate Quality AgreementsDevelop and… more
- Aldevron (Fargo, ND)
- …method validation, transfer, and development, demonstrated through publications or previous experience. Regulatory Knowledge: Strong understanding of FDA , EU, and ... that safeguard and improve human health.This position is part of the Quality and Regulatory Affairs Department located in Fargo, North Dakota and will be on-site. At… more
- Aldevron (Fargo, ND)
- …that safeguard and improve human health.This position is part of the Quality and Regulatory Affairs Department located in Fargo, North Dakota and will be on-site. At ... methods utilized at Aldevron are qualified/validated in accordance with current regulatory expectations, in a phase-appropriate manner.This role is onsite in our… more
- Cytiva (Duncan, SC)
- …related to contamination controls and sterility assurance.Ensure compliance with regulatory requirements and industry standards for sterility and contamination ... the pharmaceutical, biotechnology, or medical device industries.In-depth knowledge of regulatory requirements and industry standards for sterility assurance and… more
- Aldevron (Miami, FL)
- …regulated or GMP compliant environment and leading projects or related 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… more
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