Quality/Regulatory Manager - Wilmington - 1010 Analog Devices Inc.

    1010 Analog Devices Inc.
    1010 Analog Devices Inc. Wilmington

    6 hours ago

    Description
    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 PossibleTM. Learn more at 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 today's innovators stay Ahead of What's PossibleTM. Learn more at 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.
  • Work in company

    Regulatory Intelligence Senior Manager

    Only for registered members

    The Regulatory Intelligence Manager will play a pivotal role in monitoring, analyzing and communicating global regulatory developments that impact the client's pipeline and operations. · ...

    Wilmington

    1 month ago

  • Work in company

    Manager, Quality

    Only for registered members

    Join our Pharma Services team and be a part of a leading contract development and manufacturing organization (CDMO) offering end-to-end services for drug development, clinical trial logistics, and commercial manufacturing. · ...

    Wilmington

    2 months ago

  • Work in company

    Quality Manager

    Only for registered members

    The Laboratory Manager will lead the analytical team at Chemet Laboratory. · ...

    Wilmington $107,000 - $150,000 (USD)

    1 month ago

  • Work in company

    Manager, Quality

    Only for registered members

    Join our Pharma Services team and be a part of a leading contract development and manufacturing organization (CDMO) offering end-to-end services for drug development, clinical trial logistics, and commercial manufacturing. · Medical, Dental, & Vision benefits-effective Day 1Paid ...

    Wilmington

    1 month ago

  • Work in company

    Manager, Quality

    Only for registered members

    Join our Pharma Services team and be a part of a leading contract development and manufacturing organization (CDMO) offering end-to-end services for drug development, clinical trial logistics, and commercial manufacturing Biotech and biopharma companies trust us for our speed, fl ...

    Wilmington, NC

    1 month ago

  • Work in company

    Quality Manager

    Only for registered members

    The Quality Manager will lead the analytical team at Chemet Laboratory, performing chemical and metallurgical analyses supporting commercial nuclear fuel production for GE Vernova Hitachi Nuclear Energy. · ...

    Wilmington $107,000 - $150,000 (USD) Full time

    1 month ago

  • Work in company

    Program Manager Regulatory Medical Writing

    Only for registered members

    Join us as a Program Manager within our Regulatory Medical Writing team where you will make an impact at the forefront of innovation. · We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs spanning 2700 clinical trials across 100 countries ...

    Wilmington

    1 month ago

  • Work in company

    Senior Manager, Quality

    Only for registered members

    Pharma Services Group at Thermo Fisher Scientific is a leading contract development and manufacturing organization offering end-to-end services for drug development clinical trial logistics and commercial manufacturing. · ...

    Wilmington

    1 month ago

  • Work in company

    rn-quality management consultant

    Only for registered members

    The RN demonstrates ability and creative approaches to improvement in quality of care outcomes. · The QM Consultant demonstrates performance that improves the care for a group of patients. · ...

    Wilmington

    1 month ago

  • Work in company

    rn-quality management consultant

    Only for registered members

    A Quality Management Consultant (RN) responsible for monitoring and evaluating clinical and administrative processes for patient care at Health Care System clinics. · Current, full, active, and unrestricted registration as a graduate professional nurse in a State, Territory or Co ...

    Wilmington, NC

    1 month ago

  • Work in company

    Compliance Manager, Quality Oversight Lead-- fully remote

    Only for registered members

    Work Schedule · Standard (Mon-Fri) · Environmental Conditions · Office · Job Description · At Thermo Fisher Scientific team, you'll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top ...

    Wilmington $80,000 - $150,000 (USD) per year

    2 weeks ago

  • Work in company

    Document Control Specialist – Technical Editor

    Only for registered members

    Document Control Specialist – Technical Editor · Wilmington, NC | Global Laser Enrichment (GLE) · Full-Time | On-Site · Q-Clearance Required or Eligible · At Global Laser Enrichment (GLE), precision and compliance are essential to advancing our nuclear enrichment technology. We ...

    Wilmington OTHER

    1 hour ago

  • Work in company

    Environmental Project Manager

    Only for registered members

    Terraphase offers cost-effective solutions to complex environmental and engineering challenges. We listen to our clients and focus on their needs. We apply technical expertise and keen awareness of the regulatory framework to achieve our clients' project goals and objectives. · T ...

    Wilmington $100,000 - $130,000 (USD)

    1 month ago

  • Work in company

    Clinical Research Regulatory Coordinator

    Only for registered members

    The Clinical Research Regulatory Coordinator will act as an agent of the physician investigators and research staff conducting sponsored and independent clinical trials. · This is a hybrid position. · Applicants must be located in the Wilmington, NC area.Prepares IRB submissions ...

    Wilmington

    1 month ago

  • Work in company

    Integrated Safety Analysis

    Only for registered members

    We are seeking an experienced Integrated Safety Analysis (ISA) Manager to lead and maintain the technical rigor, · lead safety analysis for first-of-a-kind nuclear technology. · Influence design and operational decisions with direct safety insight. · ...

    Wilmington Full time

    1 month ago

  • Work in company

    Quality Control Analyst II

    Only for registered members

    Anza Mortgage Insurance is seeking a detail-oriented and highly analytical Quality Control (QC) Analyst to support our quality control review process. The QC Analyst II plays a critical role in ensuring the accuracy, completeness, and compliance of loan files submitted for mortga ...

    Wilmington

    1 month ago

  • Work in company

    Senior Hydrogeologist

    Only for registered members

    Terraphase is seeking a part-time Senior Hydrogeologist to support and lead water resources and hydrogeologic investigations. · We are an environmental consulting company that offers cost-effective solutions to complex environmental and engineering challenges. We apply technical ...

    Wilmington $100,000 - $130,000 (USD)

    1 month ago

  • Work in company

    Senior Quality Control Analyst

    Only for registered members

    +Job summary · Anza Mortgage Insurance Corporation is empowering homeownership through credit risk protection. · +QualificationsBachelor's degree in finance, business administration, or a related field. · Minimum of 5 years of experience in quality control, quality assurance, und ...

    Wilmington

    1 month ago

  • Work in company

    Independent Living Residents Director

    Only for registered members

    The Executive Director oversees the day-to-day operations, · financial performance, · and occupancy of an independent living community.Lead daily community operations, · Manage budgets, · Maintain compliance with all regulatory requirements. · ...

    Wilmington

    1 month ago

  • Work in company

    QS/ISO Leader

    Only for registered members

    This role leads the Quality Management System (QMS) for a region or product line scope. The QMS Owner and Strategist will maintain certification(s) to AS9100 and other regulatory standards. · Define and track Quality System KPIs; Use FLIGHT DECK tools to drive reviews/actions to ...

    Wilmington

    1 month ago

  • Work in company

    Portfolio Manager

    Only for registered members

    This position is primarily responsible for monitoring asset quality and assisting with the administrative functions of an assigned commercial portfolio of relationships. · Monitors the asset quality and administrative functions of each assigned portfolio relationship. · ...

    Wilmington Full time

    1 month ago

Jobs
>
Quality & regulatory manager
>
Jobs for Quality & regulatory manager in Wilmington