- Bristol Myers Squibb (Devens, MA)
- …a risk-based approach. **Key Responsibilities** * Monitor and assess global regulatory inspection outcomes, enforcement actions, quality and compliance metrics, ... and external signals, leveraging these insights to anticipate regulatory expectations, shape enterprise-wide inspection readiness strategies, and drive proactive,… more
- Pfizer (Cambridge, MA)
- …of related disciplines, eg, Clinical Operations, Safety, Biostatistics, Regulatory , Study Management, Pre-clinical, Pharmacology, Quality Assurance. ... SUMMARY** You will be responsible for scientific oversight, data integrity and quality of clinical trial(s) in support of the development strategy for programs… more
- Integra LifeSciences (Braintree, MA)
- …A minimum of 2-4 years' experience in a medical device, pharmaceuticals, Quality / Regulatory . + Compliance, or other cGMP regulated product preferred environment. ... and Drug Administration regulations, ISO 13485, and other applicable regulatory agencies as they pertain to laboratory testing. **Primary...+ Familiarity with application of FDA and/or ISO quality standards in a… more
- 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
- Nanobiosym, Inc. (Cambridge, MA)
- …+ Lead molecular diagnostic assay development in a hands-on manner through successful FDA submission + Manage and contribute to regulatory documents + Project ... managerial and leadership expertise in assay development + Strong understanding of FDA and global regulatory requirements + Prefer commercial assay experience… more
- Oracle (Boston, MA)
- …of Technical Staff to play a critical technical leadership role to ensure FDA and global regulatory compliance, including secure design, architecture and ... practices within your organization to develop and deploy high quality software at a rapid pace. You will identify...Risk-Based Process and ensure product is maintaining compliance to FDA and other Global regulatory requirements. -… more
- Takeda Pharmaceuticals (Boston, MA)
- …to track value delivery.** **_ACCOUNTABILITIES:_** + **Drive platform rationalization, data quality , and master data management strategies across Regulatory and ... projects ensuring delivery on time, within budget, and to quality standards. + Ensure all systems meet regulatory... requirements (21 CFR Part 11, GAMP 5, GDPR, FDA /EMA guidelines). + Manage and mentor a team of… more
- Sanofi Group (Cambridge, MA)
- …clinical part of regulatory documents, Common Technical Document for submission to regulatory bodies ( FDA , EMA, PMDA) and answers to questions from health ... scientists in the project in collaboration with the Safety Officer, Regulatory Strategist, Statistics and other key functional representatives to deliver development… more
- Globus Medical, Inc. (Methuen, MA)
- …we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the ... standards. Ensure timely delivery of milestones within budget and quality standards. + Adhere to the letter and spirit...medical device standards (ISO 13485, IEC 60601, etc.) and regulatory guidelines. + Support design transfer from R&D to… more
- Philips (Cambridge, MA)
- …architecture, and IT performance optimization projects. + Ensure all solutions comply with FDA validation and regulatory requirements. + Monitor and report on ... degree in information technology engineering or computer science. + Strong understanding of FDA validation, ITIL processes, and regulatory compliance. + You must… more