- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …and managing cross-functional teams. + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA , EMA, etc.). + Proven ability to ... design and deliver impactful learning programs using adult learning principles. + Experience with learning technologies (eg, LMS, virtual learning platforms) and data-driven training strategies. + Excellent communication, collaboration, and stakeholder… more
- Takeda Pharmaceuticals (Lexington, MA)
- …for medical device and digital health technologies, ensuring compliance with international regulatory requirements and Takeda Global procedures. + Lead and develop a ... fostering talent, accountability, and high performance to advance quality, ensure regulatory readiness, and drive innovation and operational excellence and execute… more
- Hologic (Marlborough, MA)
- …implement, and monitor a robust Internal Audit Program, ensuring compliance with FDA regulations, ISO standards, and other global regulatory requirements. If ... patient safety and innovation. **Knowledge** + Deep understanding of FDA Code of Federal Regulations (21 CFR 820), ISO...(eg, ISO 13485:2016, ISO 14971), MDSAP, and other global regulatory requirements. + Expertise in Quality Systems and GMP… more
- J&J Family of Companies (Danvers, MA)
- …schedules for all production equipment. + Ensure calibration traceability and compliance with regulatory and quality systems (eg, ISO 13485, FDA QSR 21 CFR ... **Performance Reporting** + Ensure calibration traceability and compliance with regulatory and quality systems (eg, ISO 13485, FDA... regulatory and quality systems (eg, ISO 13485, FDA QSR 21 CFR Part 820). **Qualifications / Requirements:**… more
- J&J Family of Companies (Danvers, MA)
- …risk management tools and methodologies (FMEA, FTA). + Experience supporting regulatory submissions and preparing verification packages for FDA /Notified Body ... devices. You will lead design verification activities in preparation for regulatory submissions and work closely with electrical, mechanical, software, and clinical… more
- Cardinal Health (Boston, MA)
- …You will develop and deploy software code and solutions that comply with FDA computer systems validation methodology. The Medical Segment IT Product team develops ... that support the Medical Device segment's Product Management, Marketing, Quality, Regulatory , and Product Design/R&D teams. Cardinal Health has deployed Oracle Agile… more
- Integra LifeSciences (Braintree, MA)
- …Review, and Quality Metrics-and plays a critical part in ensuring ongoing regulatory compliance across site operations. The Associate Manager will also support ... compliance with internal procedures, current Good Manufacturing Practices, and applicable regulatory requirements. + Lead the CAPA program, including CAPA Review… more
- Beth Israel Lahey Health (Burlington, MA)
- …knowledge of specific protocols. Implements study protocols in accordance with regulatory , departmental and institutional requirements. Uses the nursing process to ... aspects of clinical trials research adhering to Research SOPs, GCP compliance and FDA regulations. 2) Functions as a mentor, resource and educator for clinical… more
- Olympus Corporation of the Americas (Westborough, MA)
- …creation and execution of Human Factors documentation to ensure compliance with regulatory requirements in alignment with the business strategy of the company. This ... need it. + Be the point of contact for regulatory body audits and communications for the region. +...Factors in Medical Device and healthcare regulations including the FDA 2016 Guidance, 'Applying Human Factors and Usability Engineering… more
- Hologic (Marlborough, MA)
- …partner cross-functionally, mentor a high-performing team, and ensure adherence to global regulatory standards. If you're ready to make a meaningful impact by ... Systems (QMS) and electronic documentation systems. + Expertise in FDA 21 CFR Part 820, ISO 13485:2016, EU MDR...820, ISO 13485:2016, EU MDR 2017/745, and other global regulatory standards. + Expertise in managing CAPA processes, risk-based… more