- 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
- Medtronic (Santa Clara, CA)
- …for Endoscopy, ensuring compliance with ISO, FDA , and other international regulatory standards. + Lead quality initiatives to support product lifecycle ... approvals, new market entries, and portfolio expansion. + Ensure timely and high- quality regulatory submissions and interactions with global health authorities.… 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
- Abbott (Alameda, CA)
- …people's lives. **The Opportunity** Lingo is seeking an impactful Global Head of Quality and Regulatory Affairs to lead our innovative biowearables initiative ... Europe, Gulf Countries, and Asia. Overseeing all aspects of quality and regulatory affairs, from design and...regulations. + Compliance and Oversight: Ensure compliance with global regulatory standards (eg, FDA , EMA, ISO 13485,… 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
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