Regulatory Affairs Specialist

Job description

About Analog Devices Analog Devices, Inc. (NASDAQ: ADI ) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized factories, mobility, and digital healthcare, combat climate change, and reliably connect humans and the world. With revenue of more than $9 billion in FY24 and approximately 24,000 people globally, ADI ensures today's innovators stay Ahead of What's Possible™. Learn more at www.analog.com and on LinkedIn and Twitter (X) . Regulatory Affairs Specialist Summary of the Role/About the Team & Org ADI’s Digital Healthcare Group is developing novel remote monitoring solutions that improve patient care and quality of life, while keeping costs low. The Digital Healthcare Group is looking for an energetic, Principal Regulatory Affairs Specialist for the development of novel solutions. Specific Responsibilities / Duties: Provide strategic input and technical guidance on regulatory requirements for new technologies and product modifications, considering FDA regulations Prepare Pre-Sub and 510(k) submis...