- 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
- Sartorius (Marlborough, MA)
- …projects and systems meet GMP requirements and are validated according to regulatory guidelines (eg, FDA , EMA). Oversee and perform equipment qualification ... in a leadership role + Strong understanding of GMP, FDA regulations , and other applicable regulatory ...GMP, FDA regulations , and other applicable regulatory guidelines + Proven experience in process engineering, equipment… more
- Deloitte (Boston, MA)
- …support. + Regulatory Compliance: Ensure all solutions and processes meet global regulatory requirements (eg, FDA , EMA, PMDA) and industry best practices. + ... You will lead and deliver complex projects that drive innovation, regulatory compliance, and operational excellence for pharmaceutical, biotech, and medical device… more
- Takeda Pharmaceuticals (Lexington, MA)
- …sure that the HFE work is done in compliance with IEC 62366 & regulatory body (example, FDA ) expectations. Drive HF/UX initiatives in early stage, development, ... Summary report etc.) in compliance with IEC 62366 & regulatory agency expectations + Provide input to Use-Related Risk...formative and summative studies. + Familiarity with IEC 62366-1/2, FDA HF Guidance, EU MDR usability expectations + Working… more
- Dana-Farber Cancer Institute (Boston, MA)
- …the appropriate regulatory agencies including the Food and Drug Administration ( FDA ), Office of Biotechnology Activities (OBA) + Support the maintenance of the ... deviation, violation, exception, or other event reporting. Ensure various regulatory reporting required are met, Study Sponsor, FDA... regulatory reporting required are met, Study Sponsor, FDA , IRB etc. + Serve as facilitator for study… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …bring life-changing therapies to patients worldwide. The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review Lead is accountable ... medicine promotion. **How you will contribute:** + As our Associate Director, Global Regulatory Affairs Advertising and Promotion lead you will act as the Subject… more
- Oracle (Boston, MA)
- **Job Description** This role is dedicated to understanding healthcare regulatory requirements (such as HIPAA, HITRUST, FDA , etc.) and guiding cross-functional ... functions. Excellent communication, documentation, and executive presentation skills. Familiarity with regulatory frameworks (eg, HIPAA, HITRUST, FDA ) and their… more
- Olympus Corporation of the Americas (Westborough, MA)
- …support Regulatory Affairs' efforts in creating submission materials for various regulatory domains including FDA , PMDA, and EU-MDR. **Job Duties** + Advise ... support across the global organization and assists development teams in applying regulatory rigor to Agile SW development practices. This position provides subject… more