- Arthrex (Naples, FL)
- …area of usability/human factors engineering principles including standards (IEC 62366) and FDA guidance for compliance . Facilitate the planning, execution, and ... teams for design, development transfer and post-market surveillance of FDA Class I and II, EU Class I, IIa,...focus. For electrical equipment / active device projects, lead compliance efforts for electrical safety, environmental, and emissions in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …documents (eg, clinical overviews, formulary dossiers, online evidence repository). Ensure compliance with FDA requirements as they affect medical ... health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …implementation and validation of IT systems using best quality practices in compliance with FDA regulations, including cloud technologies and IT ... IS Quality function. The ideal candidate will be responsible for ensuring compliance with regulatory requirements, industry best practices and internal standards as… more
- Alpha Baking (Chicago, IL)
- …working environment for all employees, adhering to industry sanitation standards, and ensuring compliance with FDA , SQF, HACCP, FSMA, and GMP standards. This ... Provider. Conduct or take part in weekly plant GMP audit inspection. Ensure compliance with all relevant regulations, including OSHA, FDA , and local health… more
- Careers Integrated Resources Inc (West Sacramento, CA)
- …Perform the set-up, testing and troubleshooting of diagnostic panels. . Assure compliance with FDA Quality System Regulations (QSR), Good Manufacturing Practices ... written and verbal specifications in the manufacturing process while maintaining FDA requirements. . Independently execute work regarding drying and packaging of… more
- Compunnel (West Sacramento, CA)
- …tasks. Perform the set-up, testing and troubleshooting of diagnostic panels. Assure compliance with FDA Quality System Regulations (QSR), Good Manufacturing ... written and verbal specifications in the manufacturing process while maintaining FDA requirements. Independently execute work regarding drying and packaging of… more
- Arthrex (Goleta, CA)
- …functions and design development activities of Class I and II medical devices in compliance with FDA , ISO, CMDR Quality Systems and Design Control requirements. ... Assurance Experience with Medical Capital Equipment. Thorough knowledge of FDA , ISO13485 and CMDR Quality System Requirements, ISO 14971 Risk… more
- Lundbeck (Boston, MA)
- …required training, documentation, expense reporting, and other administrative responsibilities Ensures compliance with all FDA and Lundbeck requirements REQUIRED ... REXULTI PTSD following the potential launch of the PTSD indication, pending FDA approval. Maximizes and leverages key opinion leader (KOL) relationships by… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Operating Procedures, Work Instructions, Deviations, and other quality documents for cGMP compliance and consistency with FDA regulations. Aiding members of the ... the efficient execution of critical quality tasks. Fostering efficiency, maintaining compliance with cGMP and other relevant regulatory requirements, and fostering… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Operating Procedures, Work Instructions, Deviations, and other quality documents for cGMP compliance and consistency with FDA regulations. Aiding members of the ... various subunits of the Quality System and ensuring accountability. Achieving compliance with cGMP and other relevant regulatory requirements and fostering… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary The Quality Engineer is responsible for ensuring cGMP compliance of all relevant FDA regulations and internal procedures/specifications relating ... ALCOA+ guidelines. Audits - represent the company during contact with the FDA and other regulatory agency audits. Data Management- perform statistical data analysis… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of country labeling deviations for assigned Daiichi Sankyo products ensuring compliance with all applicable Health Authority (HA) regulations and guidelines, ... may manage assigned staff, partnering with the Global Labeling Operations & Compliance group and across the cross-functional and cross- regional representatives on… more
- Fidelity TalentSource LLC (Boston, MA)
- …Description:The RoleAs a member of the Fidelity Digital Asset Services, LLC (FDAS) Compliance team, you will serve as an informed and trusted business partner, who ... promotes a culture of ethical conduct and commitment to compliance , regulatory and legal obligations.\u00A0 In this role you...for securing, trading, and supporting investments in digital assets. FDA is part of the Enterprise Services portfolio of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to build a phase appropriate quality system that supports quality and compliance of Good Clinical Laboratory Practices and Good Laboratory Practices. Proactively ... identifies compliance risks impacting research unit across DSG, and assures...place.Responsible to engage directly with Health authorities such as FDA , EMA, Swiss medic, and other local authorities as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulatory process optimizations on relevant topics.Responsibilities- Supports CMC regulatory compliance activities for portfolio biologics to meet US, International ... of CMC changes and assess regulatory implications.- Participates in meetings with FDA . Prepares internal functional teams for these interactions to build strong… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Independently leads cross functional teams through all labeling discussions with the FDA /CHMP while ensuring management alignment. Strategizes and plans for FDA ... by managing labeling development or approval for either the US or EU.Ensure Compliance with Core Data Sheets/Label Changes: Manages updates to Core Data Sheets for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …relevant Standard Operating Procedures (SOPs), Food and Drug Administration ( FDA ) regulations, EU Directives, and International Conference on Harmonization (ICH) ... collaborative studies. Ensure projects align with strategic goals and compliance standards from initiation through completion.Operational Strategy: Develop and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including functional representatives, corporate representative, IT, privacy, legal, compliance , IT security, etc.Responsibilities- In conjunction with the Director ... from multiple functions, domain experts in privacy, security, and compliance and technology and IT owners from the digital...o 21 CFR § 312.32: IND Safety Reports o FDA Guidance for Clinical Investigators, Sponsors, and IRBs -… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …studies. Ensures the requirements are met for subject enrollment and compliance from entry through follow up, investigator participation, data report submission ... Maintain strong working knowledge of Standard Operating Procedures (SOPs), FDA regulations, and International Conference on Harmonization/Good Clinical Practice… more
- DivIHN Integration Inc (Atlanta, GA)
- …inputs (including but not limited to: Field Corrective Action (FCA), Complaints, FDA Medical Device Reports (MDR), etc.) to determining trends and systemic issues. ... on information analysis. Review existing investigation reports and identify gaps for GMP compliance . Develop strategies and plans to close the gaps in an efficient… more
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