- Kelly Services (Norcross, GA)
- …for medical devices, including in vitro diagnostics (IVDs). The role will support global regulatory compliance across US FDA , Health Canada, and EU Notified ... * Review and approve commercial materials (brochures, presentations, training materials) for regulatory compliance . * Maintain awareness of regulatory … more
- MetaOption, LLC (Jersey City, NJ)
- …with a focus on manufacturing and wholesale distribution. + Proven track record in FDA regulatory compliance , including cGMP, GDP, and DSCSA. + Experience ... regulatory standards. Key Responsibilities + Regulatory Compliance Oversight + Advise on FDA , DEA,...Regulatory Compliance Oversight + Advise on FDA , DEA, and state regulatory requirements for… more
- Eurofins US Network (St. Charles, MO)
- …+ Understands and follows all procedures and processes required for work performed under Regulatory Compliance (ie GxP, FDA /GLP and GCP, OECD, CLIA, etc.) ... Senior Scientist ensures study design; execution and reporting align with regulatory and client project specifications. The Senior Scientist provides critical client… more
- Brown University (Providence, RI)
- …members, ensuring that investigators receive guidance on IRB submissions, post-approval regulatory requirements, clinical trial compliance , FDA regulations, ... About the Opportunity Reporting to the HRPP Director, the Assistant Director, Compliance and Regulatory Services ("Assistant Director") provides strategic and… more
- Access Dubuque (Dubuque, IA)
- …issues, deficiencies, and questions from regulatory agencies. Other duties include: + Assures regulatory compliance to ISO 13485, FDA 21 CFR 820, and ... or guidance documents. The Regulatory Specialist is responsible for maintaining regulatory compliance as new or revisions of standards and product designs… more
- Zimmer Biomet (Austin, TX)
- …full product lifecycle + Strong understanding of design controls, risk management, and regulatory compliance ( FDA , ISO 13485, ISO 14971) + Proficiency ... partner with Quality, Regulatory , and Clinical teams to ensure design compliance with FDA , ISO 13485, and other global regulatory standards and with… more
- Stryker (Mahwah, NJ)
- …knowledge of MIM processes and tooling + Experience with process validation and regulatory compliance ( FDA , ISO 13485) Health benefits include: Medical ... guidance on MIM processes, tooling, materials, and manufacturability considerations. + Ensure compliance with FDA , ISO 13485, and internal quality system… more
- Bayer (Myerstown, PA)
- …- cGMPs) requirements. + Ensure processes are appropriately validated to conform to regulatory compliance ( FDA ) guidelines. Provides technical advice in the ... to investigate quality issues and approve packaging material specifications to ensure compliance with division and regulatory (Good Manufacturing Practices… more
- Stryker (Mahwah, NJ)
- …Proficiency in CAD software (SolidWorks, Creo) + Familiarity with validation protocols and regulatory compliance ( FDA , ISO 13485). Health benefits include: ... & Validation: + Execute IQ/OQ/PQ validation protocols to ensure compliance with FDA and ISO 13485 standards....production risks. + Maintain DHF and DMR documentation for regulatory compliance . + Drive Lean and Six… more
- CVS Health (Annapolis Junction, MD)
- …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
- Stanford Health Care (Palo Alto, CA)
- …Administration, Clinic Managers and clinic staff on pharmacy-related issues such as regulatory changes/ compliance , FDA drug recalls, drug information, ... prevention through timely issue identification and follow-up. + Supports regulatory audits and other compliance requirements. +...federal and state levels. + Knowledge of other relevant regulatory guidelines (eg, CMS, 340B, FDA ). +… more
- Reckitt (Salt Lake City, UT)
- …Monitoring samples in conformance with all relevant safety and quality requirements. + Ensure regulatory compliance with FDA , USP, EU, ISO and cGMP ... of highly skilled talents that include Scientists, Engineers, Medical, Clinical and Regulatory professionals - all working to create a cleaner, healthier world. With… more
- Caris Life Sciences (Phoenix, AZ)
- …operates within Caris' global Quality System and Regulatory framework, maintaining compliance with applicable FDA , ISO 13485, CAP, and CLIA standards. The ... and internal training programs to maintain up-to-date knowledge of applicable regulatory and compliance standards (eg, FDA , ISO 13485, CAP/CLIA). +… more
- Schwan's Company (Minneapolis, MN)
- …providing expert guidance on regulatory requirements, product safety, labeling compliance (USDA/ FDA ), and special claims to support safe and compliant ... across the supply chain? As our Sr Manager, FSQ Regulatory Compliance , you will play a critical...meat, eggs etc), FDA ). * Experience supporting regulatory audits and managing import/export compliance . Compensation… more
- LiDestri (Fairport, NY)
- …development files, process deviation files, and regulatory process filing files for regulatory compliance ; Filing with FDA and California as needed + ... and food sterilization equipment to ensure commercial sterility in compliance with food industry regulations + Calculate cook time...requirements + Support the submission of processes to the FDA via website + Hands on preparation and communication… more
- Reckitt (Wilson, NC)
- …maintenance, and QMS frameworks. + Ensure documentation adheres to GDP standards and regulatory compliance ( FDA , ICH, ISO); support validation and hygiene ... and equipment reliability while aligning with plant performance and GMP compliance goals. **Your responsibilities** + Lead execution of tableting and coating… more
- Eurofins US Network (Lenexa, KS)
- …LCMS strategies for complex modalities such as peptides, ADCs, and oligonucleotides. + Ensure regulatory compliance with FDA , EMA, and ICH guidance. + Manage ... and clinical drug development. We specialize in delivering high-quality, regulatory -compliant data through innovative bioanalytical services. As we expand our… more
- ManpowerGroup (Milwaukee, WI)
- …Prepare and issue blood components for transfusion. + Maintain accurate records and ensure regulatory compliance ( FDA , AABB, CLIA, OSHA, CAP). + Operate and ... maintain lab equipment and reagents. + Provide consultation and support to healthcare providers. + Participate in quality improvement and training initiatives Employees are eligible for a comprehensive benefits package based on job classification including… more
- US Foods (Lexington, NC)
- …food safety, quality, and preventative maintenance. * Support the FSQA Manager to Ensure regulatory compliance with USDA, FDA , State and local authorities ... and raw material compliance specifications * Manage labeling compliance with USDA/ FDA regulations * Ensure complete data collection and trending on relevant… more
- Medexus Pharma (CT)
- …diverse audiences (internal and external). + Knowledge of medical affairs processes, regulatory compliance (GCP, FDA /EMA), pharmacovigilance, and safety ... Provide timely and accurate responses to medical inquiries in compliance with regulatory and ethical standards. +...responses to medical inquiries in compliance with regulatory and ethical standards. + Collaborate cross-functionally with … more