- Dana-Farber Cancer Institute (Boston, MA)
- …II oversees trial startup coordination, trains site research staff, handles regulatory submissions, tracks safety events, and communicates with regulatory ... with an emphasis on optimizing trial processes and ensuring adherence to regulatory standards. **This is a full-time,** **40-hour** **per week position. As a… more
- Sanofi Group (Cambridge, MA)
- …skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting the medical ... GRA Device organization serves as a critical strategic partner within Sanofi's regulatory framework, providing expert guidance on medical device regulatory … more
- Takeda Pharmaceuticals (Cambridge, MA)
- …will participate in US and global integrated brand teams, advising on FDA laws and regulations, anti-kickback and bribery statutes, false claims acts, transparency ... and helping the teams manage and mitigate legal risk. + Advising on FDA laws and regulations, anti-kickback and bribery statutes, false claims acts, transparency… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …methods, fixtures, and workflows are reliable, scalable, efficient, and compliant with regulatory standards. This role focuses on building robust, automated test and ... methods, fixtures, and workflows are reliable, scalable, efficient, and compliant with regulatory standards. This role focuses on building robust, automated test and… more
- Catalent Pharma Solutions (Chelsea, MA)
- …+ Participated in managing and fronting Regulatory Inspections from both EU and US Regulatory agencies such as MHRA, IBM, FDA , USDA; + Ability to work under ... establish, document and monitor Quality standards and requirements that meet Catalent, Regulatory and Customer requirements; + To ensure that the site complies with… more
- Astrix Technology (Devens, MA)
- …to develop and optimize systems and processes aligned with company strategy and regulatory requirements. + Provide support for customer, regulatory , and internal ... and supplier audits to ensure compliance with ISO and FDA Quality System Regulation (QSR) standards. + Collect, review,...+ 3-5 years of relevant experience in a quality, regulatory , or laboratory environment. + Strong knowledge of ISO… more
- Edwards Lifesciences (Boston, MA)
- …with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize ... Clinical Science/Medical Writing is responsible for supporting the development of regulatory and clinical documents for a dynamic portfolio of products across… more
- Beth Israel Lahey Health (Burlington, MA)
- …general research duties. Implements study protocols in accordance to regulatory and institutional requirements. Works closely with principal investigators, research ... medical conditions and diagnoses. **Job Description:** 1) Possesses ongoing knowledge of FDA , OHRP and GCP regulations: + Ensures adherence to regulations. +… more
- Integra LifeSciences (Braintree, MA)
- …and manage time to meet organizational goals and objectives. + Experience with External Regulatory Agency audits (ie, Notified Bodies and FDA ). + Knowledge of ... activities. The role works with Product Development, Project Management, Regulatory , Marketing and Medical Affairs. **ESSENTIAL DUTIES AND RESPONSIBILITIES** +… more
- Medtronic (Boston, MA)
- …mitigation strategies in accordance with IEC 81001-5-1, ISO 14971, and FDA premarket cybersecurity guidance. + **Security Architecture & Design** - Collaborate ... through documentation, review participation, and active knowledge sharing. + ** Regulatory & Standards Compliance** - Ensure alignment with applicable standards… more