Principal Regulatory Affairs Specialist

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).

Principal 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) submissions and technical documents to support CE mark and other international submissions   

• Participate in negotiations and interactions with regulatory authorities during the development and review process   

• Support international product registrations as needed  

• Manage multiple projects and prioritize tasks on day-by-day basis to meet project schedules  

• Interface with engineering, quality, clinical, marketing, and other functions as needed to fulfill responsibilities  

• Review promotional and advertising material  

• Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards  

• Create or revise departmental procedures to improve operations or to reflect changing regulatory requirements  

• Participate in internal and external audits as needed  

• Maintain Regulatory affairs documentation to support compliance with applicable regulatory requirements  

• Ensure compliance with design controls in accordance with ISO 13485 standard and 21 CFR 820 regulation.  

• Manage Internal Audit program in accordance with ISO 13485 and MDSAP and host all 3rd party audits including FDA. 

• Provide training of QMS processes   

• Perform other duties as assigned or required  

Previous Experience/Skills Needed & Education Requirements 

• MS Regulatory Affairs 

• Experience with ISO 13485, MDSAP and FDA QSR 

• Should be willing to learn & shouldn’t be afraid of getting their hands dirty! 

For positions requiring access to technical data, Analog Devices, Inc. may have to obtain export  licensing approval from the U.S. Department of Commerce - Bureau of Indust