- Integra LifeSciences (Braintree, MA)
- …Reviews, and Gate Reviews. + Lead and support the execution of all Risk Management and Usability Engineering process activities, including design, process, and ... application FMEAs. + Author or review for approval other Risk Management Documentation: Risk ...5+ years of experience in Quality Assurance role for medical device or pharmaceutical manufacturing, or equivalent… more
- Hologic (Marlborough, MA)
- …technology companies + Passionate about global privacy and data protection law, as well as medical device technology policy more broadly + A passion for people ... mission to make our global security platform a solid differentiator in the Medical Technology industry. With your passion and energy in leading our global privacy… more
- Takeda Pharmaceuticals (Boston, MA)
- …patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant management of regulatory change control and post-approval activities at the site ... This position leverages ICH Q12 principles to streamline post-approval change management and explores automation to enhance predictability and repeatability in… more
- Integra LifeSciences (Braintree, MA)
- …Reviews, and Gate Reviews. + Understand and support the execution of all Risk Management and Usability Engineering process activities, including design, process, ... and application FMEAs. + Review for approval other Risk Management Documentation: Risk ...3+ years of experience in Quality Assurance role for medical device or pharmaceutical manufacturing, or equivalent… more
- Cardinal Health (Mansfield, MA)
- …Services Center perform laboratory testing to characterize the chemistries of our medical device products and stability testing for pharmaceutical products of ... + Strong knowledge of ICH guidelines, FDA regulations, Data Integrity, Quality Risk Management and other pharmaceutical regulatory requirements, preferred. +… more
- Insight Global (Bedford, MA)
- Job Description This role ensures that design control and risk management activities for software and digital medical products (SaMD, SiMD) meet all required ... and cloud-based applications. - Project design, validation, quality planning, and risk management (including human factors and cybersecurity). - Regulatory… more
- AbbVie (Waltham, MA)
- …liquid, solids, and/or device products and elevates medium and high risk events to AbbVie management . Leads the collection, verification and improvement ... medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's… more
- Hologic (Marlborough, MA)
- …needs. **What we expect:** + The preferred candidate's should include project or program management in NPD for medical device development. + Bachelor's ... complex NPD, business, commercial, or operations projects in medical device industry. + Strong project management skills including: budgeting, planning,… more
- J&J Family of Companies (Danvers, MA)
- …experience, black belt preferred. + Experience with SAP preferred, or another ERP, device management and procurement systems. **Other:** + Willingness to travel, ... for humanity. Learn more at https://www.jnj.com/. **_Key Responsibilities:_** **Category Management ** + Develop and/or support the category sourcing strategy for… more
- Insight Global (Quincy, MA)
- …use case sequence diagram - Cybersecurity concepts: MFA, best practices, encryption standards, device biometrics - Cybersecurity risk assessment - AWS / Genesys ... but nice to have - Cybersecurity concepts: MFA, best practices, encryption standards, device biometrics - Cybersecurity risk assessment - Solution Architect to… more