- Takeda Pharmaceuticals (Lexington, MA)
- …across multidisciplinary teams to deliver device clinical outcomes that exceed quality benchmarks and regulatory standards. **Core Responsibilities:** **Device ... into technical requirements + Coordinate risk mitigation activities across clinical, regulatory , quality , and engineering functions + Perform safety reviews… more
- Abbott (Burlington, MA)
- … system improvement activities. + Comply with US Food and Drug Administration ( FDA ) regulations, EUMDR, and other regulatory requirements and Abbott policies, ... Burlington, MA location in the Abbott Heart Failure Division Global Design Quality Department. In Abbott's Heart Failure (HF) business, we're developing solutions to… more
- Hologic (Marlborough, MA)
- …R&D, Regulatory Affairs, and Manufacturing Engineering teams to embed quality and compliance principles into every stage of development and post-market ... safety, effectiveness, and innovation. **Knowledge:** + Deep expertise in FDA 21 CFR Part 820 Quality System...writing and communication skills for preparing and presenting complex regulatory and quality concepts to diverse audiences.… more
- Astellas Pharma (Westborough, MA)
- …team members on method development and validation, documentation practices, and Quality Assurance principles + ** Regulatory Compliance:** Ensure all ... qualification and validation activities comply with relevant regulatory requirements, including FDA and EMA guidelines...+ Leadership and mentorship capabilities + Strong knowledge of Quality Assurance and regulatory principles + Ability… 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
- 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
- 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