- Oracle (Boston, MA)
- …patient safety, usability, and compliance across our next-generation EHR and AI-enabled medical device platforms. As a Clinical Product Manager ( Medical ... is standing up a specialized clinical product management team focused on medical device -aligned products. This team bridges clinical practice, product strategy,… more
- Oracle (Boston, MA)
- …as Regulatory Affairs, Quality Compliance , Product Development, etc. in medical device industry or equivalent. Experience authoring submissions (510k, EU ... success and competitiveness in the healthcare and life sciences sector. As a Medical Device Regulatory Affairs Strategist, you will work in collaboration with… more
- Sanofi Group (Framingham, MA)
- …(GRA) Device team is a globally diverse team supporting the medical device , combination product, digital health and in-vitro diagnostic (IVD) products ... strategic partner within Sanofi's regulatory framework, providing expert guidance on medical device regulatory requirements across the product lifecycle. Our… more
- Sanofi Group (Cambridge, MA)
- …(GRA) Device team is a globally diverse team supporting the medical device , combination product, digital health and in-vitro diagnostic (IVD) products ... strategic partner within Sanofi's regulatory framework, providing expert guidance on medical device regulatory requirements across the product lifecycle. Our… more
- Takeda Pharmaceuticals (Lexington, MA)
- …degree with 15+ years of experience** + Minimum 5 years of combination product, medical device , or pharmaceutical industry experience + Experience with both ... Develop Device Clinical Development Strategy for Combination Products and Medical Devices + Develop comprehensive risk management strategies for devices and… more
- Intertek (Boxborough, MA)
- Project Engineer - Medical Device Testing, Boxborough, MA Intertek, a Nationally Recognized Testing Lab (NRTL) and leading provider of quality and safety ... and companies is actively seeking a Project Engineer - Medical Device Testing to join our Electrical...conduct on and off-site evaluation of products to determine compliance with applicable standard(s). + Read and determine applicability… more
- Globus Medical, Inc. (Methuen, MA)
- …in mechanical and electrical engineering principles, ensuring robust hardware solutions and compliance with medical device standards while driving innovation ... design. + Foster a culture of innovation, collaboration, accountability and compliance with medical device standards. Ensure timely delivery of milestones… more
- Globus Medical, Inc. (Methuen, MA)
- …of algorithm and software engineers. + Foster a culture of innovation, collaboration, and compliance with medical device standards. + Adhere to the letter ... in algorithms and software with leadership experience in regulated medical device environments and has a track...ISO 13485 and FDA guidelines. + **Regulatory & Quality Compliance ** + Ensure adherence to IEC 62304 ( medical… more
- J&J Family of Companies (Boston, MA)
- …moral character while professionally representing the company. + Comply with all corporate compliance , FDA, medical device , quality standards and ethics. + ... portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and… more
- Hologic (Marlborough, MA)
- …understanding of FDA Quality System Regulations, ISO 13485, and Medical Device Directive. + Expertise in compliance issues and regulatory expectations. + ... and compliance . **Experience:** + Minimum 12+ years in the medical device industry. + Proven track record in quality system strategy, risk management,… more