Quality/Regulatory Manager

Analog Devices•Wilmington, MA

30d•Remote

About The Position

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). 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.

Requirements

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.

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.