- Cytiva (Pensacola, FL)
- …Pensacola site's Quality Management Representative, leading QA/QC functions, ensuring regulatory compliance , and aligning with organizational quality ... Operations within Life Sciences, Biotechnology, Medical Device, Biopharma, or other FDA or EPA-regulated manufacturing environments.Possess a minimum of 4 years of… more
- Cytiva (Miami, FL)
- …equipment, or systems to increase production capacity and improve process performance ensuring compliance with regulatory requirements (eg, FDA , ISO, PSM) ... 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)
- …related field or material science fields with 15 years of progressive Regulatory compliance and / or quality assurance experience.Thorough understanding of ... processes and/or procedures advises on impact of regulations, devises strategies for compliance , and liaison with regulatory bodies. Investigates and resolves … 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...adhere to these requirements throughout the product lifecycle. Ensure compliance with labeling regulations, such as 21 CFR Part… more
- Beckman Coulter Diagnostics (Miami, FL)
- …of medical devices, engineering, or quality assurance.Strong knowledge of Quality, Regulatory compliance , and operations systems and processes, including GMP ... local, state and federal environmental regulations and standards including compliance with Food & Drug Administration ( FDA ),...submission of audit responses and requests for information to FDA , MDSAP Notified Body and other Regulatory … more
- Aldevron (Miami, FL)
- …creation, implementation and maintenance of all Quality and release processes in compliance with all foreign and domestic regulatory and statutory requirements. ... results.Serve as the site's primary contact with both customers and regulatory agencies regarding quality/ compliance issues and Negotiate Quality… more
- Cytiva (Duncan, SC)
- …change control processes related to contamination controls and sterility assurance.Ensure compliance with regulatory requirements and industry standards for ... the pharmaceutical, biotechnology, or medical device industries.In-depth knowledge of regulatory requirements and industry standards for sterility assurance and… more
- Aldevron (Miami, FL)
- …risk assessment using FMEA, HCCAP, and Quality by Design in compliance with Aldevron and cGMP policies, procedures, rules, and regulations.Job QualificationsBachelor ... regulated or GMP compliant environment and leading projects or related experience.Exposure to regulatory agency inspections or other types of audits (eg, FDA ,… more
- Actalent (Orlando, FL)
- …Clinical research + Regulatory knowledge + IRB regulatory submission + Regulatory compliance + FDA regulations + Oncology and clinical trial ... is based in an office setting, focusing on electronic document management and regulatory compliance tasks. Pay and Benefits The pay range for this position is… more
- Kelly Services (Gillette, WY)
- …regulatory teams to meet safety and efficacy standards. ** Regulatory and Compliance Expertise:** + Lead FDA strategy and submission efforts for INDs, ... to shaping the future of healthcare. As a **Senior FDA Regulatory Affairs Specialist** , you will...collaborate with internal teams and external partners to ensure FDA compliance and successful product development from… more
- The Hershey Company (AZ)
- …of a world-class manufacturing environment. * Role Responsibilities*: * Acts as leader for FDA regulatory compliance , FDA and State inspections, and ... developing the sites HACCP program, building Food Safety and Quality Plans and ensures compliance with all FDA and state regulations for food production. This… more
- Integra LifeSciences (Irvine, CA)
- …and polymers. + Extensive experience in validation protocols (IQ/OQ/PQ), risk mitigation, and regulatory compliance ( FDA , ISO 13485, GMP). + Proficiency in ... and execute validation strategies (IQ/OQ/PQ) for new products, processes, and equipment in compliance with ISO 13485 and FDA regulations. + Identify and engage… more
- CVS Health (Alexandria, LA)
- …regulatory and compliance developments (eg, state Board of Pharmacy, DEA, FDA , etc.) for pending regulatory changes and partner with Division ... + Communicate and educate staff on pharmacy-related issues such as regulatory changes/ compliance , FDA drug recalls, drug information, sample medications, and… more
- ThermoFisher Scientific (Richmond, VA)
- … adherence in laboratory operations. The position requires strong leadership, expertise in regulatory compliance (eg, CLIA, CAP, FDA , ISO 15189), and ... Regulatory Compliance Accreditation + Ensure compliance with relevant regulations, including CLIA, CAP, FDA...in a senior leadership role + Extensive experience in regulatory compliance (CLIA, CAP, FDA ,… more
- dsm-firmenich (Tonganoxie, KS)
- …nutrition, feed, or food manufacturing. + Experience with lab testing, GMP, HACCP, and regulatory compliance (eg, FDA , AAFCO, FSSC 22000). + In Experience ... with lab testing, GMP, HACCP, and regulatory compliance (eg, FDA , AAFCO, FSSC 22000). + Ability to identify inconsistencies and ensure adherence to strict… more
- Smartbridge (Houston, TX)
- …executives (CXOs, CTOs, CIOs, or technology decision-makers). ✔ Strong understanding of regulatory compliance ( FDA , GxP, HIPAA), data-driven R&D, automation, ... such as data & analytics, AI/ML, intelligent automation, cloud modernization, and regulatory compliance solutions. + Educate Life Sciences executives on how… more
- Catalent Pharma Solutions (Philadelphia, PA)
- …shift for production related activities that require quality input and oversight. Ensures regulatory compliance with FDA cGMPs, DEA requirements, Clinical ... to identify operating efficiencies to continuously improve and promote compliance + Educates Production/ Project Management on regulatory...an advantage + Good knowledge of the application of FDA cGMP's + Individual may be required to sit,… more
- Globus Medical, Inc. (Limerick, PA)
- …ensuring compliance with all company policies and procedures. Lead and enforce regulatory compliance with US FDA , State, OSHA and international medical ... and operations while ensuring compliance with all regulatory requirements including US FDA , State, OSHA,...skills and ability to train personnel in Quality and Regulatory Compliance . **Physical Demands** **:** The physical… more
- Applied Materials (Gloucester, MA)
- …AI-driven platforms, or manufacturing automation software. + Strong understanding of **GMP, regulatory compliance ( FDA , EMA), and pharma manufacturing ... leverages AI, IoT, and automation to optimize production efficiency, ensure regulatory compliance , and drive real-time decision-making. We empower pharmaceutical… more
- University of Utah (Salt Lake City, UT)
- …sequencing ( NGS ) is a plus. 6. Knowledge of GMP requirements, aseptic processing, and regulatory compliance (eg, FDA , FACT , USP , and ICH guidelines). ... quality control, and manufacturing teams to improve production workflows and ensure regulatory compliance . * Identify and implement automation, analytics, and… more
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