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In this role, you will be responsible for ensuring food products are accurately labelled and in compliance with all US labeling regulations as mandated by FDA, Customs and USDA. You will support all regulatory-related activities, including but not limited to: researching industry updates pertaining to labeling compliance; supporting the review processes for packaging, marketing materials, and digital information.
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Basic knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations. ADVENT's services include process engineering, automation engineering, project engineering, facility/system design, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.
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Keeps abreast of and ensures compliance with regulatory practices (e.g. FDA, EMA, and ICH guidance and recommendations) and industry data standards (e.g. CDISC). Represents Emmes at Sponsor, Regulatory, Investigator or Safety Review meetings (e.g., Data and Safety Monitoring Board Meetings.
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SUMMARY: The EHS Specialist works with Environmental Health and Safety Director to plan, direct, and implement Key Cooperative's environmental health and safety programs to ensure a positive, safe, healthy, and incident-free work environment and is responsible for the compliance by Key Cooperative with all environmental and safety regulatory agencies.
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Compliance and Regulatory Support: Stay up to date with relevant regulatory guidelines and industry standards (e.g., FDA, GMP) pertaining to MES systems. Knowledge of regulatory guidelines and standards, such as FDA regulations, GMP, and data integrity requirements.
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As a Senior QA Associate, Compliance/QA Lead , you would be responsible for ensuring product compliance to established cGMPs, to meet safety and quality standards for FDA Regulatory and customer requirements by adherence to Standard Operating Procedures (SOPs.
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Other / Regulatory: Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA, HIPAA, HCFA, DPW, LCGME, SCGME, etc) Flexible and readily adopts new processes and engages in practice operation changes.
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The Senior Ethics & Compliance Specialist/Regulatory Support Manager is a subject matter expert on FDA regulations, the university's policies, processes, and standards. This role requires the incumbent to also provide administrative, regulatory and policy support across all functional units within the Office of Ethics & Compliance (OEC), as needed.
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Ensures that vehicle manifests, labeling and load are in compliance with regulatory guidelines such as those pertaining to the Department of Transportation (DOT), Environmental Protection Agency (EPA), Federal Motor Carrier Safety Administration (FMCSA), Food & Drug Administration (FDA), Occupational Safety and Health Administration (OSHA), and Airgas safety standards (SAFECOR.
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Experience:Quality assurance experience in a healthcare environment, OPO environment, Tissue Recovery Agency, quality/regulatory affairs, manufacturing and/or process auditing desired. Leads and assists with external inspections and surveys conducted by New York State Department of Health (NYSDOH), Food and Drug Administration (FDA), Center for Medicare & Medicaid Services (CMS), and United Network for Organ Sharing (UNOS/OPTN.
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While not required, it will be a plus if the person has practical understanding, interpretation, and application of US FDA regulatory requirements for Dietary Supplements. Reporting to a regional Regulatory Head, the Regulatory Manager is responsible for contributing to the development and implementation of compliance policies, processes and programs for the country business, which in the US, it consists of cosmetics, medical devices, dietary supplements, electrical products, medicines, and/or household consumer chemical products.
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Establish and maintain policies and procedures to ensure compliance with local, state and federal environmental regulations and standards including compliance with all Food & Drug Administration (FDA) and European Union Medical Device Directives (MDD)/European Union Medical Device Regulation (MDR) as well as all other applicable global regulatory requirements.
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In this role, you will define, implement and maintain the validation program for the site, ensuring compliance to the company quality guideline, FDA regulatory requirements, and cGMP regulations.
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Reviews sample run data and quality control data and ensures all regulatory compliance standards are met while following established SOPs. Ensures proper entry of specimen data and testing results into databases or the laboratory information management system (LIMS), providing oversight of junior staff activities.
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Design, prototype, test and troubleshoot embedded electronics firmware and cloud-based databases using a variety of digital design tools, with emphasis on design best practices and compliance with relevant regulatory requirements.
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