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) . Employer: Analog Devices, Inc. Job Title: Senior Strategist - Quality and Regulatory Job Requisition: R255590 Job Location: Wilmington, Massachusetts Job Type: Full Time Rate of Pay: $210,891.00 per year 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 3rd 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 3rd 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. Partial telecommute benefit (2 days WFH permitted). Requirements: Must have a Master's degree in Regulatory Affairs, Engineering, Life Sciences, or a related field (willing to accept foreign education equivalent) and five (5) years of experience as a Regulatory Affairs Specialist or related occupation 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. Must also possess the following (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.
- DE Conducting supplier audits. Contact: Eligible for employee referral program. Apply online at and Reference Position Number: R255590 . 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
- Actual wage offered may vary depending on work location , experience, education, training, external market data, internal pay equity, or other bona fide factors.
- This position qualifies for a discretionary performance-based bonus which is based on personal and company factors.
- This position includes medical, vision and dental coverage, 401k, paid vacation, holidays, and sick time, and other benefits.