- Sanofi Group (Cambridge, MA)
- …eg, the small and heterogeneous patient populations, limited historical data, regulatory pathways (eg, FDA /EMA accelerated approval, orphan drug designation), ... in gene therapy clinical trials, a rapidly evolving field with unique regulatory and methodological considerations. The intern will engage in literature review, case… more
- TE Connectivity (Medway, MA)
- …all activities performed within TE Medical + Leads and supports audits from external regulatory agencies ( FDA , BSI, JPAL) and customers and to lead preparation ... the design development of Design History Files (DHF) for new products and ensures regulatory compliance. + Leads and demonstrates expertise in the areas of QSR and… more
- Pfizer (Boston, MA)
- …Injectables experience, including buy-and-bill strategies and demonstrated knowledge of: Regulatory pathways ( FDA , EMA, Health Canada) and interchangeability ... public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses… more
- Bristol Myers Squibb (Devens, MA)
- …data flow and strong information security. + Ensure strict adherence to GxP, FDA , and other applicable regulatory standards in system implementation, validation, ... understanding of CSV (computer system validation), data integrity, and regulatory requirements in laboratory environments. + Proven leadership, people management,… more
- Cytel (Boston, MA)
- …comfortable interfacing with **senior executives** . + Experience interacting with ** regulatory agencies ( FDA /EMA)** and **key opinion leaders (KOLs)** . ... collaborating with a team of consultants and analysts to define optimal ** regulatory , clinical, and/or market access pathways** . + Develop **innovative solutions**… more
- AbbVie (Worcester, MA)
- …SCADA, and Data Historian systems. + Ensure all automation systems comply with regulatory requirements ( FDA , cGMP, etc.). + Mitigates risk within functions ... responsible to provide the necessary support during the internal and external regulatory audits. Qualifications + Bachelor's degree in computer science or related… more
- J&J Family of Companies (Danvers, MA)
- …sustainability. + **Safety, Quality & Regulatory Compliance** + Maintain alignment with regulatory expectations (eg, FDA QSR/21 CFR Part 820, ISO 13485) and ... This role owns scale-up, process validation, root-cause investigations, safety, regulatory compliance, and continuous improvement initiatives. You will mentor… more
- Cognizant (Boston, MA)
- …systems. + Manage Computer System Validation (CSV) activities in alignment with global regulatory standards ( FDA , EMA, MHRA). + Utilize ALM tools to streamline ... testing workflows and ensure traceability across the validation lifecycle. + Collaborate with R&D and business teams to align testing efforts with project goals and timelines. **Work model:** We believe hybrid work is the way forward as we strive to provide… more
- ThermoFisher Scientific (Plainville, MA)
- …facts; draw valid conclusions; and make decisions. + Thorough understanding of regulatory guidelines ( FDA , EMA, and other relevant authorities). + Excellent ... troubleshooting skills with the ability to resolve complex technical issues. + Strong interpersonal and communication skills, both verbal and written. **Work Environment/Physical Requirements** + This position requires working regular business hours and, when… more
- Philips (Cambridge, MA)
- …with medical device products or medical device integration and working with the FDA and other global regulatory bodies. + Familiarity with healthcare technology ... solutions like EPIC, Cerner, etc., preferred. + Experience working directly with hospital/health systems customers in technical, clinical, and leadership roles and the creation of compelling value propositions for these roles. + Experience with integration… more