- Oracle (Boston, MA)
- …Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring ... Knowledge of ISO 14971, IEC 62366, EU MDR/IVDR, and FDA guidance related to medical device software (SaMD). ..... Experience supporting regulatory submissions or audits (EU MDR, FDA 510(k), etc.). . Experience working with AI-driven medical… more
- Hologic (Marlborough, MA)
- …recommending actions. + Participate in internal and external audits, including FDA inspections and supplier audits. + Support monthly Quality Investigation Review ... + 2-5 years' experience in engineering, ideally within an FDA -regulated industry. + Experience in root cause analysis or...is beneficial. **Skills & Attributes:** + Working knowledge of FDA Quality System Regulations, ISO 13485, EU Medical Device… more
- Takeda Pharmaceuticals (Boston, MA)
- …of technical success for the solutions. + Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports ... point of contact with health authorities, leads and manages FDA meetings and/or other regional HA meetings as appropriate....of drug development process and regulatory requirements. Knowledge of FDA , EU, Canada, ROW and post-marketing a plus. +… more
- Hologic (Marlborough, MA)
- …C (Recalls), 21 CFR Part 806 (Reports of Corrections and Removals), FDA Quality System Regulations, ISO 13485:2016, and EU Medical Device Regulation regarding ... field safety corrective actions. + Familiarity with FDA Industry Guidance for Recalls and guidance on distinguishing recalls from medical device enhancements. +… more
- Philips (Cambridge, MA)
- …acquired a minimum of 7+ years' experience in Regulatory Affairs/Strategy within FDA regulated Medical Device environments. + You have proven expertise in Software ... EUMDR tech files, and Pre-Sub notifications submitted to the FDA . + Your skills include familiarity with FDA... FDA . + Your skills include familiarity with FDA , EU MDR, Health Canada, and other relevant international… more
- Takeda Pharmaceuticals (Boston, MA)
- …and communicating in a professional and timely manner. + Accountable for US FDA submissions and approvals of project(s) of responsibility. May serve as the primary ... FDA point of contact for projects of responsibility. +...of drug development process and regulatory requirements. Knowledge of FDA , EU, Canada, ROW and post-marketing a plus. +… more
- Takeda Pharmaceuticals (Boston, MA)
- …as global and/or regional regulatory lead as a member of a GRT + Primary FDA contact for projects of responsibility. + Accountable for all US FDA submissions ... + Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA is a must. Knowledge of EU, Canada, ROW is a plus. + Experience… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …lifecycle + Subject matter expert on EFPIA, IFPMA, and FDA code/regs, guidance, industry standards, complaints/violations, and innovative promotional platforms ... Regulatory Subject Matter Expert: Provide expertise on EFPIA, IFPMA, and FDA codes, regulations, guidance, industry standards, and innovative promotional platforms.… more
- Takeda Pharmaceuticals (Lexington, MA)
- …+ Ensure global compliance with applicable medical device and software regulations (eg, FDA 21 CFR Part 820, ISO 13485, ISO 14971, MDR/IVDR, MDSAP). + Act ... of global regulations and guidances governing medical device, including FDA 21 CFR Part 820, ISO 13485, ISO 14971,...In-depth knowledge of global medical device and SaMD regulations ( FDA , ISO 13485, ISO 14971, MDR/IVDR, MDSAP). + Proven… more
- Hologic (Marlborough, MA)
- …for verification/validation activities. + Maintain accurate records and documentation per FDA and other regulatory requirements. + Interact with internal and ... process and/or product development environment. **Skills:** + Experience with FDA Quality Systems Regulation, especially Design Control requirements, ISO 13485,… more