Quality/Regulatory Manager US, MA, Wilmington

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 todays innovators stay Ahead of Whats Possible™. Learn more at www.analog.com and on LinkedIn and Twitter (X). Job Description: Quality and Regulatory Manager Job Title: RA/QA Manager Location: US-based , Wilmington, MA (remote will be considered) Function: Regulatory and Quality Reports to: Business Lead 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 todays innovators stay Ahead of Whats Possible™. Learn more at www.analog.com and on LinkedIn and Twitter (X). You will be working within a small, stealth group of talented individuals at ADI focused on next-generation technologies solving some of the world’s toughest problems around human and planetary health. We are seeking an experienced and highly motivated Quality and Regulatory Manager to lead the development, implementation, and maintenance of our Quality Management System (QMS) and oversee regulatory submissions for medical devices and life science products. The ideal candidate will have proven expertise in U.S. FDA regulatory submissions, including successful 510(k) approvals, and will ensure compliance with applicable domestic and international regulations. Key Responsibilities • Develop, implement, and maintain a comprehensive Quality Management System (QMS) aligned with ISO 13485, FDA QSR, and other applicable regulations. • Lead the preparation, submission, and maintenance of regulatory submissions including FDA 510(k), CE Mark Technical Files, and international registrations. • Ensure company-wide compliance with all relevant quality and regulatory standards. • Manage internal and external audits, inspections, and corrective/preventive actions (CAPA). • Provide regulatory strategy and guidance to cross-functional teams during product development and commercialization. • Establish and maintain policies, procedures, and training programs to support quality and regulatory compliance. • Monitor changes in global regulatory requirements and advise management on their potential impact. • Serve as the primary liaison with regulatory agencies and notified bodies. • Lead risk management activities and ensure compliance with ISO 14971 requirements. • Support post-market surveillance activities, including complaint handling and adverse event reporting. Qualifications and Experience • Bachelor’s degree in Life Sciences, Engineering, Regulatory Affairs, or related field (Master’s preferred). • Minimum of 10 years of progressive experience in quality and regulatory roles within the medical device or life sciences industry. • Proven track record of successful FDA 510(k) submissions and approvals. • Strong knowledge of ISO 13485, FDA QSR, ISO 14971, MDR, and other relevant regulatory frameworks. • Experience managing QMS development, implementation, and continuous improvement. • Demonstrated ability to interface effectively with regulatory bodies, auditors, and internal teams. • Excellent organizational, leadership, and communication skills. • Ability to work independently and collaboratively in a fast-paced environment. 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 The expected wage range for a new hire into this position is $106,500 to $159,750. • 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. Apply tot his job