- Stanford Health Care (Palo Alto, CA)
- …staff, clinic managers, nurse managers, etc.) on medication-related issues such as regulatory changes/ compliance , FDA drug recalls, drug information, sample ... Clinic Managers and clinic staff on pharmacy-related issues such as regulatory changes/ compliance , FDA drug recalls, drug information, special programs,… more
- TestPros (Silver Spring, MD)
- …an FDA project. The ideal candidate will have a strong background in regulatory compliance , particularly with FDA regulations, and will ensure that all ... in testing and documentation. + Regulatory Knowledge: In-depth understanding of FDA regulations and compliance requirements. + Leadership: Ability to guide… more
- Charles River Laboratories (Ashland, OH)
- …Understanding PK/TK and metabolic processes + Significant depth of knowledge in regulatory compliance ( FDA /EMA/EPA) as relates to bioanalytical sciences ... methods from the method development are fit-for-purpose, and ready for FDA /EMA validation guidelines (where appropriate). + Ensure on-time and quality delivery… 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
- Healgen Scientific Limited (Houston, TX)
- …and manufactured material consistently meets design, QA, and manufacturing requirements and meets regulatory compliance with FDA , ISO, and IVD Regulation. ... proper documentation practices to ensure compliance with FDA , ISO, and other regulatory requirements as...compliance with FDA , ISO, and other regulatory requirements as applicable. Responsibilities Work with a cross-functional… more
- DEKA Research & Development (Manchester, NH)
- …collaborative environment + Preferred working knowledge of Quality Management Systems (QMS) and regulatory compliance ( FDA , ISO 13485, etc.) About DEKA: One ... to verify system functionality. Conduct validation to ensure all systems meet regulatory and business standards. + Maintenance: Provide ongoing technical support and… more
- System One (Lakewood, CO)
- …with external teams on significant matters. + Develop technical specifications and ensures regulatory compliance ( FDA ). + Direct phases of complex ... collaborate closely with cross-functional teams to ensure product design meets both regulatory standards and customer needs. You'll lead efforts in agile development… more
- US Foods (Greensburg, PA)
- …maintenance. Enforce production suspension to ensure food safety and quality continuity. Ensure regulatory compliance with USDA, FDA , State and local ... Food People! Maintain, update, and implement national food safety and quality and regulatory compliance programs. Implements and maintains the GFSI FS22000 food… more
- MicroVention, Inc. (Aliso Viejo, CA)
- …is responsible for assisting in obtaining regulatory approvals and ensuring compliance to FDA and international regulatory agency requirements including ... the team. + Aides in the execution of the regulatory plan for the assigned market(s) based on the...plan for the assigned market(s) based on the approved regulatory strategy. + Assists in preparing regulatory … more
- Catalent Pharma Solutions (Philadelphia, PA)
- …activities related to Manufacturing and Packaging operations at Catalent Philadelphia. Supports regulatory compliance with FDA cGMPs, DEA requirements, ... promote compliance + Educates Quality/ Production/ Project Management on regulatory and customer requirements which impact upon the achievement of appropriate… more
- University of North Carolina- Chapel Hill (Chapel Hill, NC)
- …Skills: Minimum of 7 years of experience in research coordination or management. Knowledge of research, regulatory compliance ( FDA , ICH , GCP ) and ability ... to understand a clinical protocol and research contracts. Capable of independent decision making and maintaining orderly study records according to federal and University regulations, familiarity with databases. Experience in creating administrative tools,… more
- US Foods (Spokane Valley, WA)
- …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
- Vanderbilt University Medical Center (Nashville, TN)
- …requirements. . The VUMC Laboratory Quality Management Department is in need of an FDA Regulatory Affairs Manager to join the team! **This position is eligible ... **Organization:** Director's Administration **Job Summary:** Leads VML's responses to the recent FDA LDT regulations. Develops a team to support our LDT efforts and… more
- System One (Durham, NC)
- Job Title: QA Consultant (GCP Compliance ) Location: Remote with potential travel to company sites as needed. Hours/Schedule: 20hrs/wk for first few months, then ... to assist a biotech company in preparing for an FDA audit with a strong focus on Good Clinical...with a strong focus on Good Clinical Practice (GCP) compliance . The ideal candidate will have a deep understanding… more
- Balchem (Faribault, MN)
- …+ Familiarity with GMPs for food and dietary supplements, with experience in FDA regulatory compliance and relevant quality standards. + Strong ... activities and experimental results. Ensure adherence to GMP protocols, regulatory requirements, FDA compliance , and relevant quality standards. + Contribute… more
- Lundbeck (Deerfield, IL)
- …of product documentation intended for regulatory submissions for accuracy and compliance with FDA regulations. Manages, reviews and represents US ... and expectations are achieved in an optimal and compliant manner; ensures compliance with regulatory requirements and corporate standards; maintains candid and… more
- Unilever (San Francisco, CA)
- … + Collaborate cross-functionally and provide regulatory expertise to ensure compliance with applicable FDA and FTC regulations. + Use risk ... of labels, supplement facts panels, formulas, and ingredients for regulatory compliance . + Support the Olly...Extensive knowledge of FDA , FTC, and USDA's regulatory requirements and compliance in dietary supplements… more
- MD Anderson Cancer Center (Houston, TX)
- …employees and the public. This position will be responsible for the regulatory and quality oversight of MD Anderson's FDA regulated investigational ... preparation and maintenance. Ensures high-quality and timely delivery of IND/IDE regulatory submissions in compliance with all applicable regulatory… more
- BioFire Diagnostics, LLC. (Hazelwood, MO)
- …Scrum, etc. + Version Control: Familiarity with version control systems, such as Git. + Regulatory and Compliance : FDA , QSR and ISO quality systems preferred ... Benefits at bioMerieux: Low-cost medical, dental, and vision benefits starting day one 11 paid holidays160 hours of paid time offAnnual bonus9.5% 401k company contribution with no vesting periodTuition reimbursement up to $10000 per calendar yearOnsite… more
- Unilever (El Segundo, CA)
- …projects. **What You Have:** + 3-5 years of regulatory and/or compliance experience in an FDA -regulated industry; dietary supplement experience is strongly ... **Position Overview:** Reporting to the Director of Regulatory Affairs, the Certification Compliance Specialist will maintain the VMS Co-Op compliance … more
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