- ThermoFisher Scientific (Plainville, MA)
- …2-3 years experience leading teams in a fast-paced environment required. + Experience with regulatory inspections from the FDA , EMA, Health Canada, or other ... and drive efficiency throughout the organization. + Support internal, external, and regulatory inspections as needed. + Hire and develop employees within the… more
- Abbott (Burlington, MA)
- …system improvement activities. + Comply with US Food and Drug Administration ( FDA ) regulations, EUMDR, and other regulatory requirements and Abbott policies, ... or an equivalent combination of education and experience. + Knowledge of FDA regulations and guidance, ISO 13485, ISO 14971, Software Standards (eg, 62304),… more
- Insight Global (Westborough, MA)
- …Pipelines), and others as applicable. The role ensures these tools align with regulatory requirements (eg, FDA , IEC 62304, ISO 13485) and supports system ... knowledge of compliance frameworks relevant to SaMD (IEC 62304, ISO 13485, FDA CFR Part 11). * Excellent communication, problem-solving, and documentation skills. *… more
- Cytel (Cambridge, MA)
- …Medidata Rave, Oracle Inform, Veeva, or similar). + Excellent understanding of ICH-GCP, FDA , EMA, and other global regulatory guidelines. + Strong attention to ... individual brings advanced knowledge of medical terminology, clinical trial processes, regulatory requirements, and coding best practices. The Senior Medical Coder… more
- Dana-Farber Cancer Institute (Boston, MA)
- …donor status including progress, challenges, and adjustments. + Ensure compliance with all regulatory bodies (eg, FDA , AABB, FACT, NMDP) related to donor ... logistical, and administrative aspects of donor services, ensuring compliance with regulatory standards and supporting overall operations of the Cellular Therapy… more
- Curia (Boston, MA)
- …transfer, qualification and validation of biologics based analytical methods using the ICH, FDA and EMA guidelines and regulatory requirements. + Multiple years ... for equipment. + Provide technical support to clients for regulatory filings, change control and quality impact assessments. +...other Curia sites. + Keep site informed for new regulatory , ICH requirements in RNA, proteins and other biological… more
- Nanobiosym, Inc. (Cambridge, MA)
- …and international tax regulations while managing government contracts and healthcare-related regulatory requirements (eg, FDA , IRB approvals, and liability ... environment and is ready to tackle a wide range of legal, regulatory , and compliance challenges. The ideal candidate is a skilled negotiator, exceptional… more
- Integra LifeSciences (Braintree, MA)
- …to resolve environmental control issues. + Ensure compliance with safety, environmental, and regulatory standards (eg, FDA , ISO). + Maintain accurate records of ... management systems (BMS) and automated environmental controls. + Knowledge of regulatory requirements in the medical device or pharmaceutical industry. + Experience… more
- Nanobiosym, Inc. (Cambridge, MA)
- …+ Prior in-house legal experience in a biotech or pharmaceutical company. + Familiarity with regulatory frameworks (eg, FDA , EMA) as they relate to IP. ... matters, including licensing agreements, collaborations, M&A due diligence, and regulatory submissions. + Dispute Resolution: Support IP litigation, opposition… more
- Oracle (Boston, MA)
- …**Oracle Cloud SCM, Manufacturing, Quality, and ERP** integrations. + Knowledge of ** regulatory compliance processes** ( FDA , ISO, cGMP) and quality documentation ... management. + Familiarity with **Oracle Visual Builder Studio** , **BI Publisher** , and **Reports** for PLM analytics. + Certification in **Oracle Cloud PLM or PDH** modules. + Strong understanding of **product data governance frameworks** and enterprise data… more