- Curia (Hopkinton, MA)
- …of the conditions and activities in the manufacturing facility to ensure continual compliance with cGMP. This position requires expertise in all aspects of Biologics ... Through a quality system approach, ensure all GMP operations are in compliance , while maintaining an efficient workflow to facilitate operational excellence +… more
- Catalent Pharma Solutions (Chelsea, MA)
- …and quality specialists; + Demonstrate knowledge of International Quality and Compliance standards and requirements, with preferable FDA experience; + ... a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer,...EU and US Regulatory agencies such as MHRA, IBM, FDA , USDA; + Ability to work under pressure to… more
- Nanobiosym, Inc. (Cambridge, MA)
- …Nanobiosym was awarded the first X-Prize to be given for healthcare. The Compliance Engineer is responsible for the organization and the coordination of processes ... pertaining to regulatory compliance and quality systems...creation and documentation of validation protocols that comply with FDA regulations. + Provide troubleshooting focus and direction for… more
- Integra LifeSciences (Braintree, MA)
- …resources, planning to meet goals and deadlines + This role ensures compliance within the document management system, document storage, retention, and document ... a document control reviewer for new and revised procedures and documents to ensure compliance with global and site procedures as needed + Ability to manage multiple… more
- Medtronic (Boston, MA)
- …for medical devices and embedded systems. It is not an IT security, compliance , or GRC-focused position. The ideal candidate will have deep experience working with ... mitigation strategies in accordance with IEC 81001-5-1, ISO 14971, and FDA premarket cybersecurity guidance. + **Security Architecture & Design** - Collaborate… more
- Catalent Pharma Solutions (Chelsea, MA)
- …is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer, and Catalent employee.** **The ... Part11 assessments and GMP evaluations of control systems to ensure they meet FDA requirements + Prepares standard operating procedures for new and existing control… more
- Merck (Boston, MA)
- …response to product inquiries and adverse reports in accordance with internal, FDA , CFIA and USDA regulatory policies. The successful candidate for this position ... aimed at answering customer and industry questions, monitoring protocol compliance , and summarizing results from post-approval marketing support trials specific… more
- Integra LifeSciences (Braintree, MA)
- …of new or improved quality control systems as needed. + Ensure compliance with industry regulations, company policies, and safety standards during the transition ... and analyze process data. + Assist in preparing for, and participating in FDA audits, internal audits, and other regulatory agencies audits. + Demonstrate excellent… more
- Integra LifeSciences (Braintree, MA)
- …or other product development studies. + Assist in preparing for and participating in FDA audits, customer audits, etc. + All other duties as assigned DESIRED MINIMUM ... of 2-4 years' experience in a medical device, pharmaceuticals, Quality/Regulatory Compliance , or other cGMP regulated product preferred environment. + Familiarity… more
- Biomat USA, Inc. (Worcester, MA)
- …daily activities of donor floor operations, supervising staff, and supporting compliance with regulatory and quality standards. The Senior Operations Supervisor acts ... staff during assigned shifts. + Learns and maintains thorough familiarity and compliance with all state and federal regulations, US Food and Drug Administration… more