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, AI, and software technologies into solutions that combat climate change, reliably connect humans and the world, and help drive advancements in automation and robotics, mobility, healthcare, energy and data centers. With revenue of more than $11 billion in FY25, ADI ensures today's innovators stay Ahead of What's Possible. Learn more at www.analog.com and on LinkedIn and 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) 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!

#LI-CC1

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.

Job Req Type: Experienced

Required Travel: Yes, 10% of the time

Shift Type: 1st Shift/Days