- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized ... with local and global requirements as well as applicable regulatory requirements. + Works collaboratively with local and global...requirements and the Drug Development process. + Knowledge of FDA 21 CFR Parts 210 and 211. + Experience… more
- Hologic (Marlborough, MA)
- …quality, we want to hear from you! **Knowledge:** + In-depth understanding of FDA Quality System Regulations, ISO 13485, and Medical Device Directive. + Expertise in ... compliance issues and regulatory expectations. + Advanced knowledge of Quality Management Systems...resolution. + Collaborative mindset to work cross-functionally with R&D, Regulatory , Marketing, and Quality teams. + Proactive and adaptable… more
- Cardinal Health (Boston, MA)
- …maintains security policies and IT compliance programs in alignment with regulatory , legal, and contractual requirements, while collaborating closely with key ... IT operations, projects, and M&A activities are aligned with enterprise standards, regulatory requirements and industry's best practices. In this role, you will have… more
- Sumitomo Pharma (Boston, MA)
- …but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, Data Management and Biostatistics is essential. **Job Duties ... as required. + Coordinate responses to ad hoc safety issues such as regulatory authority, site, or health care professional requests, along with PV physician,… more
- Hologic (Marlborough, MA)
- …and validation (V&V) strategies, ensuring our software meets the highest global regulatory standards. If you're an experienced professional with a strong background ... in software engineering, regulatory compliance, and mentoring, this is your opportunity to...Deep understanding of global medical device software regulations, including FDA 21 CFR Part 820, EU MDR, ISO 13485,… more
- Takeda Pharmaceuticals (Boston, MA)
- …in pharmacovigilance by adopting new technologies for automation/intelligence while maintaining regulatory compliance. + They will play a key role as SME ... Lead E2B program expansion based on business needs and interpretation of global regulatory changes + Support MedDRA upgrade and related activities + Perform data… more
- Sanofi Group (Waltham, MA)
- …activities (when applicable), including quality, relevance to external stakeholders (eg regulatory authorities, medical journals), and scientific validity. We are an ... success. + Contribute with project team members (ie: clinical, pharmacovigilance, regulatory , ) to gain Health Authorities acceptance of the plans, accountable… more
- Cardinal Health (Chicopee, MA)
- …to ensuring equipment reliability, reducing downtime, and maintaining compliance with FDA , ISO, and DEP standards and regulations. **Responsibilities:** + Perform ... departments with new product trials, testing and validations per regulatory requirements. (IQ/OQ/PQ). + Collaborate with engineering, quality, and production… more
- Medtronic (Boston, MA)
- …Ensure all software verification activities adhere to relevant medical device regulations (eg, FDA 21 CFR Part 820, ISO 13485, IEC 62304) and internal quality ... cross-functionally with software development, systems engineering, quality assurance, and regulatory affairs teams to ensure seamless integration and verification of… more
- Bristol Myers Squibb (Devens, MA)
- …delays and zero errors. + Provide clearance information to the designated brokers, FDA and other government agencies for entries. + Relay release information to ... to ensure that inbound shipments are not manipulated with or disbursed prior to FDA Release, as applicable. + Maintain and automate an Import Checklist to ensure… more