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 FY22 and approximately 25,000 people globally working alongside 125,000 global customers, ADI ensures today's innovators stay Ahead of What's Possible. Analog Devices, Inc. ("ADI") is filing an Application for Alien Employment Certification for the below described job description: Position: Senior Strategist - Quality and Regulatory (Wilmington, Massachusetts) Duties: As part of the ADI Medical Product Group, guide the development of procedures to support the process flow for medical products' including manufacturing production processes and complaints and Failure Analysis procedures. Coordinate and document ongoing complaints process with ADI partners including communication with FDA, as necessary. Coordinate Supplier Audit and Internal Audit programs in accordance with ISO 13485 and host all third party audits including FDA. Maintain medical Quality Management System documentation and processes and tools in accordance with ISO 13485 standard and 21 CFR 820 regulation. Ensure compliance with Documentation Control and Records processes that meet the Computer System Validation requirements for 21 CFR Part 11. Support Internal Audit program in accordance with ISO 13485 and host all third party audits including FDA. Collaborate between Medical Quality Management System (MQMS) and ADI processes for process efficiency while keeping MQMS independence. Provide training of MQMS processes for Medical Products personnel. Requirements: Master's degree in Regulatory Affairs, Engineering, Life Sciences, or closely related technical discipline (willing to accept foreign education equivalent) and five (5) years of experience as a Regulatory Affairs Specialist or experience executing the complete lifecycle of product registrations before national and international regulatory agencies, including documenting internal processes for quality control, and coordinating post-market surveillance and reporting activities. Specific skills/other requirements - Demonstrated Expertise (quantitative experience requirements not applicable to this section): Demonstrated expertise (DE) filing and securing two or more approvals of the CE Marking designation for Class 2 or higher for medical devices; DE establishing and maintaining an International Organization for Standardization (ISO) 13485 and medical device single audit program (MDSAP) Quality Management System (QMS) for a medical devices manufacturer; DE maintaining a QMS according to ISO and FDA regulations, including participating and responding to audit requests; DE delivering trainings on regulatory and quality procedures to comply with regulatory standards including ISO 13485 and FDA Quality System Regulation.; and DE Conducting supplier audits. Eligible for employee referral program. Apply online at https://www.analog.com/en/about-adi/careers.html and Reference Position Number: R241250 Salary: $195,458.00/year 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: No Shift Type: 1st Shift/Days