- Fresenius Medical Center (Lawrence, MA)
- …: + 3+ years of clinical or healthcare marketing experience. Experience in medical devices , diagnostics or pharmaceuticals is desirable. + Experience translating ... in-center products Ensure all materials are reviewed and approved through appropriate regulatory and medical review processes. **PHYSICAL DEMANDS AND WORKING… more
- Wolters Kluwer (Waltham, MA)
- …portfolio of on-market medical devices including Software as a Medical Device (SaMD) within the Health Division in Wolters Kluwer. Important ... 510(k)s, labeling and promotional materials, 21 CFR 820, global medical device registration, technical writing, and external... regulatory standards and laws applicable to the medical device industry eg, ISO, QSR, GMP.… more
- Takeda Pharmaceuticals (Lexington, MA)
- …+ Develop Device Clinical Development Strategy for Combination Products and Medical Devices + Develop comprehensive risk management strategies for devices ... device , or pharmaceutical industry experience + Experience with both medical devices , drug- device combination products, digital health technologies… more
- Abbott (Burlington, MA)
- …entering information into the complaint database; independently determining and filing appropriate medical devices reports with various regulatory agencies; ... complaints. Independently assesses the complaint to determine if a medical device report needs to be filed... Reporting) + Knowledge of the use, development, and regulatory environment of medical devices … more
- Philips (Cambridge, MA)
- …of 8+ years' Regulatory Affairs experience within FDA regulated Medical Device /HealthTech product environments. Experience with Software as Medical ... As a critical member of the Philips Ultrasound- Regulatory Affairs Organization, the Principal Regulatory ...Technical Documentation, 510(k), De Novo, PMA, and registrations of medical devices globally. + You're able to… more
- Eliassen Group (Marlborough, MA)
- …subsystems and systems. . Create design documentation to support medical device product development in alignment with regulatory requirements and industry ... **Mechanical Engineer- R&D, Medical Device ** **Marlborough, MA** **Type:** Contract.... Collaborate with cross-functional teams, including R&D, clinical, and regulatory , to review documentation and specifications to ensure alignment… more
- IQVIA (Boston, MA)
- …area guidance for clinical development plans in compliance with applicable regulatory , medical , and ethics guidelines. + Ensure high-quality, data-driven ... leaders, and identifying new business opportunities. + Provide due diligence scientific, medical , regulatory , and drug development expertise and activities for… more
- Sanofi Group (Cambridge, MA)
- …(3+ years preferred) of regulatory experience, preferably within the pharmaceutical/ medical device /biotech industry + Knowledge and understanding of complex ... **Job Title:** Associate Director, Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge,...R&D colleagues, as well as other stakeholders (eg, Legal, Medical , Marketing, Communications and Compliance). + Participates in the… more
- Takeda Pharmaceuticals (Boston, MA)
- …safety issues with other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, Manufacturing, and ... the Company-wide patient safety expert for assigned pharmaceutical / biological / drug- device combined products, accountable for the safety strategy and major safety… more
- Medtronic (Newton, MA)
- …intuitive, user-friendly interfaces that enhance the usability and functionality of our advanced medical devices . The Senior Software Engineer will be a key ... and debugging software that interfaces with hardware components. Experience with regulatory compliance and security protocols specific to medical software… more
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