Staff Regulatory Affairs Specialist

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 $12 billion in FY23 and approximately 26,000 people globally working alongside 125,000 global customers, ADI ensures today’s innovators stay Ahead of What’s Possible. Learn more at www.analog.com and on LinkedIn and Twitter (X)

          

Staff Regulatory Affairs Specialist: 

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 prioritise tasks on day-by-day basis to meet project schedules 

Interface with engineering, quality, clinical, marketing, and other functions as needed to fulfil 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 

• Perform other duties as assigned or required 

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 Industry and Security and/or the U.S. Department of State - Directorate of Defense Trade Controls.  As such, applicants for this position – except US Citizens, US Permanent Residents, and protected individuals as defined by 8 U.S.C. 1324b(a)(3) – may have to go through an export licensing review process.

Analog Devices is an equal opportunity employer. We foster a culture where everyone has an opportunity to succeed regardless of their race, color, religion, age, ancestry, national origin, social or ethnic origin, sex, sexual orientation, gender, gender identity, gender expression, marital status, pregnancy, parental status, disability, medical condition, genetic information, military or veteran status, union membership, and political affiliation, or any other legally protected group.

EEO is the Law: Notice of Applicant Rights Under the Law.

Job Req Type: Experienced

          

Required Travel: Yes, 10% of the time

          

Shift Type: 1st Shift/Days