- Pall (Miami, FL)
- …Danaher Business System which makes everything possible.Director Global Quality and Regulatory ComplianceJOB SUMMARYInterprets federal/state/international ... or material science fields with 15 years of progressive Regulatory compliance and / or quality assurance...AS9100 / CAA Part 145/CAA Part 21 standards. GMP, FDA knowledge and other ISO standards an advantage.Good understanding… more
- Cepheid (Miami, FL)
- …about the Danaher Business System which makes everything possible.The Senior Quality Systems Specialist is responsible for functioning as Lead Internal Auditor ... to schedule, plan, perform, and document internal audits of Cepheid's Quality Management System (QMS), providing continuous and rigorous assessment to identify and… more
- Beckman Coulter Diagnostics (Miami, FL)
- …qualifications, and ongoing performance assessments to ensure adherence to internal quality standards, customer requirements, and applicable external regulatory ... and supply continuity risks.Collaborate with cross-functional teams across R&D, Procurement, Operations, Quality , and Regulatory Affairs to embed quality … more
- Aldevron (Miami, FL)
- …of solutions that safeguard and improve human health.This position is part of the Quality and Regulatory Affairs Department located in Fargo, North Dakota and ... 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
- Sanofi Group (Framingham, MA)
- …and roll-out of the Sanofi Quality Management System in line with US FDA cGMP regulatory requirements, Pharmaceutical Quality System ICH Q10 and Sanofi ... Global Quality . . **Core member of critical governance** + Sanofi's GMP GDP Quality Council to facilitate sharing of US FDA inspection findings and best… more
- Philips (Bothell, WA)
- …the right fit if:** + You've acquired a minimum of 10 years' experience in FDA regulated quality / regulatory environments, with a focus on Post Market ... Surveillance / Complaint Handling / Regulatory Reporting / Quality Operations and a...self-growth, empowerment, and continuous improvement. + You have prior FDA and other regulatory audits/inspections experience is… more
- Prose (Brooklyn, NY)
- …continuously improve a robust, compliant QMS that aligns with GMP, ISO 22716, and FDA regulatory standards. + Ensure quality policies, SOPs, and ... the internal audits findings to assess compliance with internal and regulatory quality standards. + Manage the lifecycle of CAPAs-from initiation through… more
- Unither Pharmaceuticals (Rochester, NY)
- …*Areas of expertise should include most, if not all of the following: GMP, FDA , regulatory affairs and compliance, quality assurance and controls, ... of our specifications. [True/Fair/Challenging] * Respect for any new project the technical, regulatory and quality obligations issued by the Management and … more
- Actalent (Davis, CA)
- …web browsers and learning new software tools. Regulatory Knowledge + Familiarity with FDA Quality System Regulations (21 CFR Part 820), ISO 13485, ISO 14971. ... is a full-time onsite role in Davis, CA (Monday-Friday) Department: Quality and Regulatory Position Summary A growing life sciences organization is seeking a… more
- Stryker (Redmond, WA)
- …and risk assessments + Ensure compliance with internal quality procedures and regulatory requirements, including FDA Quality System Regulations (QSR's) + ... **Customer Quality Engineer (Hybrid)** _Redmond, WA_ Stryker is seeking a **Customer Quality Engineer** to join our team in Redmond, WA. This hybrid role… more
- Hologic (Marlborough, MA)
- …including those conducted by the FDA , notified bodies, and other regulatory agencies. + Quality System Compliance: Ensure adherence to applicable ... The Manager of Quality Engineering will lead quality strategies to ensure compliance with regulatory ...regulatory standards, including ISO 13485, FDA QMSR and other applicable requirements. + Review and… more
- Bayer (NJ)
- …Bayer seeks an incumbent who possesses the following: **Required Qualifications:** + US FDA regulatory experience in related drug or device area; + Demonstrated ... strategies for key projects, achieving fast, resource efficient submissions of high- quality dossiers, driving Food and Drug Administration ( FDA ) communications… more
- Novo Nordisk (Plainsboro, NJ)
- …within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education ... related pharmaceutical or medical device/pharmaceutical combination product experience and actual regulatory experience + Advanced knowledge of pertinent FDA … more
- Actalent (Piscataway, NJ)
- Job Title: Quality Assurance and Regulatory Affairs SpecialistJob Description As a Quality Assurance and Regulatory Affairs Specialist, you will play a ... regulatory strategies for a clinical laboratory. + Prepare regulatory submission documents for the FDA or...Support and participate in audits and inspections by sponsors, regulatory authorities, and clients. + Support Quality … more
- Fujifilm (College Station, TX)
- **Position Overview** **Summary:** The Quality Assurance Regulatory Affairs Supervisor is responsible for supporting the electronic publishing of regulatory ... Ensure timely approvals, communicate, and support negotiations with the FDA and other regulatory bodies as needed...of two (2) years of related experience in a regulatory , quality , or similar position. + Prior… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …execute comprehensive regulatory strategies for SaMD products in alignment with FDA regulations and guidance documents. + Provide regulatory input during the ... including evaluation of cybersecurity risks. + Collaborate with R&D, Quality , Marketing, and Regulatory teams to ensure...Guidance and SaMD related Guidance. + Knowledge of international regulatory requirements (eg, FDA QSR, ISO 13485,… more
- Houston Methodist (Houston, TX)
- …study team and sponsor's regulatory team. This position communicates with regulatory affairs office for FDA submissions across multiple studies of different ... **SERVICE ESSENTIAL FUNCTIONS** + Ensures compliance of general and study-specific regulatory and/or safety-related processes with SOP's, FDA , GCP, NIH… more
- Kentucky Blood Center (Lexington, KY)
- …OSHA, EU, and short supply agreement requirements. Reports to the Vice President, Quality and Regulatory Affairs; supervises the QA team. $2,500 Sign-On Bonus ... levels of the organization to ensure compliance and the fulfillment of quality initiatives and regulatory requirements. + Participates in training activities,… more
- Tecomet (Manchester, NH)
- **POSITION SUMMARY:** The Quality Assurance & Regulatory Affairs Manager oversees the quality management system (QMS) and ensures compliance with 21 CFR | ... Part 820, ISO 13485, ISO 14971, AS9100, and applicable regulatory standards. This role manages Quality Engineering and Inspection teams, leads audits,… more
- Kemin Industries (Des Moines, IA)
- Overview Kemin Health is hiring an Associate Director of Regulatory /Scientific Affairs and Quality ! In this role, you will be responsible for leading the ... business units' regulatory affairs (RA) and quality assurance (QA)...regulatory entities, including, but not limited to US FDA , EFSA, Health Canada, ANVISA, etc. + Responsible for… more
