- ITW (Burlington, MA)
- …in process and final inspection of products and components used in NRC/ FDA regulated environment. **Primary Responsibilities** + Mechanical inspection + Tensile and ... and acceptance criteria + Assists with testing of product to demonstrate regulatory compliance + Assist with investigating problems and recommending / implementing… more
- J&J Family of Companies (Danvers, MA)
- …and continuous improvement initiatives. You will mentor engineers, partner across R&D, Quality , Regulatory , and Supply Chain, and drive cost savings and ... + Lead critical programs from concept through commercialization, ensuring alignment with regulatory , quality , and business goals. + **Scale-Up & Design/Process… more
- Oracle (Boston, MA)
- …for Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring ... Excellent cross-functional communication and documentation skills. Preferred: . Experience supporting regulatory submissions or audits (EU MDR, FDA 510(k),… more
- Oracle (Boston, MA)
- …for Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring ... Excellent cross-functional communication and documentation skills. Preferred: . Experience supporting regulatory submissions or audits (EU MDR, FDA 510(k),… more
- J&J Family of Companies (Danvers, MA)
- …and collaborative leader capable of working across functions, including engineering, quality , regulatory , supply chain, and cybersecurity, to ensure the ... and patient safety. + Cross-Functional Collaboration: Work closely with R&D, Quality , Regulatory , Cybersecurity, Supply Chain, and Manufacturing teams to… more
- Hologic (Marlborough, MA)
- …device process and/or product development environment. **Skills:** + Experience with FDA Quality Systems Regulation, especially Design Control requirements, ISO ... for verification/validation activities. + Maintain accurate records and documentation per FDA and other regulatory requirements. + Interact with internal… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …developing and executing the global GxP training strategy to ensure compliance with regulatory requirements and foster a strong quality culture across the ... lead the global GxP training strategy aligned with corporate quality objectives and regulatory standards. + Establish...training content is accurate, current, and aligned with global regulatory requirements ( FDA , EMA, ICH). **Compliance &… more
- J&J Family of Companies (Danvers, MA)
- …production equipment. + Ensure calibration traceability and compliance with regulatory and quality systems (eg, ISO 13485, FDA QSR 21 CFR Part 820). ... as needed. **Performance Reporting** + Ensure calibration traceability and compliance with regulatory and quality systems (eg, ISO 13485, FDA QSR 21 CFR Part… more
- J&J Family of Companies (Danvers, MA)
- …software, and clinical engineers while collaborating with cross-functional partners in Quality , Regulatory , Manufacturing, and Supply Chain. You will translate ... methods; summarize results and provide actionable technical conclusions. + Coordinate with Quality and Regulatory to prepare verification packages for … more
- Sartorius (Marlborough, MA)
- …projects and systems meet GMP requirements and are validated according to regulatory guidelines (eg, FDA , EMA). Oversee and perform equipment qualification ... with at least 3+ years in a leadership role + Strong understanding of GMP, FDA regulations , and other applicable regulatory guidelines + Proven experience in… more