Analog Devices · 20 hours ago
Quality/Regulatory Manager
Wilmington, MA
Full-time
Hybrid
Senior Level, Lead/Staff
$106K/yr - $160K/yr
10+ years expAnalog Devices, Inc. is a global semiconductor leader focused on bridging the physical and digital worlds. They are seeking an experienced Quality and Regulatory Manager to lead the development and implementation of their Quality Management System and oversee regulatory submissions for medical devices and life science products.
DSPElectronicsLightingSemiconductor
No H1B
U.S. Citizen Only
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
Qualification
Required
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
Benefits
Medical, vision and dental coverage
401k
Paid vacation
Holidays
Sick time
Other benefits
Company
Analog Devices
Analog Devices (NYSE: ADI) defines innovation and excellence in signal processing. ADI's analog, mixed-signal, and digital signal
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$4.6MKey Investors
U.S. Department of Defense
2025-04-11Post Ipo Debt
2024-09-18Grant· $4.6M
2012-04-02IPO
Leadership Team
Vincent Roche
Chief Executive Officer and Chair of the Board of Directors
John Hassett
SVP Industrial & Consumer Group
Recent News
2026-01-06
2025-12-22
2025-12-15
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