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.
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.
Job Req Type: ExperiencedRequired Travel: Yes, 10% of the time
Shift Type: 1st Shift/Days
Skills Required
- MS in Regulatory Affairs
- Experience with ISO 13485
- Experience with MDSAP
- Experience with FDA QSR (21 CFR 820)
- Experience preparing Pre-Submissions and 510(k) submissions
- Experience supporting CE mark and other international submissions
- Experience managing internal audit programs and hosting 3rd party audits including FDA
- Experience maintaining QMS documentation and providing QMS training
Analog Devices Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Analog Devices and has not been reviewed or approved by Analog Devices.
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Retirement Support — The 401(k) program is described as a standout feature, with company contribution up to 8% of base salary and immediate vesting. This structure strengthens long-term value even when cash compensation perceptions vary.
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Healthcare Strength — Health coverage is positioned as comprehensive, including medical, dental, and vision options along with disability and life insurance. Day-one eligibility and multiple plan choices add to perceived robustness.
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Leave & Time Off Breadth — Paid time off appears broad, with vacation ranging from roughly 17–25 days and increasing up to five weeks with tenure, alongside sick time and paid holidays. Parental leave and related time-off provisions further expand coverage.
Analog Devices Insights
What We Do
Analog Devices, Inc. (NASDAQ: ADI) operates at the center of the modern digital economy, converting real-world phenomena into actionable insight with its comprehensive suite of analog and mixed signal, power management, radio frequency (RF), and digital and sensor technologies. ADI serves 125,000 customers worldwide with more than 75,000 products in the industrial, communications, automotive, and consumer markets. ADI is headquartered in Wilmington, MA.
