Senior Director, Quality Assurance & Regulatory Strategy
Moximed
A leading medical device company in California is seeking an experienced professional to lead Quality Assurance and Regulatory Affairs teams. This role requires 15+ years of experience in medical device quality assurance and strong leadership skills. The successful candidate will manage compliance with FDA regulations and direct quality initiatives. Candidates with experience in orthopedic medical devices will be preferred. The organization values diversity and offers competitive compensation and benefits. #J-18808-Ljbffr
- WHAT YOU'D DO Quality Assurance: Provide leadership to the existing Quality Assurance team including... ...consultants who contribute to regulatory submissions, ensuring that appropriate... ...impact on current and future development strategies. Regulatory Affairs: Lead and develop...SeniorRegulatoryFlexible hours
- ...Personalis, Inc. in Fremont, CA, is seeking a Sr. Manager / Associate Director, Quality Audits to lead the global Internal Audit program and supervise readiness for external regulatory inspections in a highly regulated medical device/IVD environment. This role requires...Regulatory
$140k
We are currently seeking a Quality Manager. The Quality Manager is... ...Management and Control Strategy. The role ensures that quality... ...efforts in continuous improvement, regulatory compliance, and customer... ...data, trends, and insights to senior management, auditors, and customers...RegulatoryTemporary workWork at officeLocal areaRemote work- ...Stryker is hiring a Senior Staff Clinical Quality Associate for our Neurovascular... ...governance, and regulatory readiness across global clinical... ...compliance risks and control strategies to stakeholders across... ...clinical research, quality assurance, compliance, or a related...SeniorRegulatoryFull time
$155k - $180k
...individual to join us as a Senior Manager, External... ...-on role reporting to the Director, External Manufacturing &... ...on-time supply which meets quality, compliance and regulatory requirements Lead cross... ...partner with the Quality Assurance group, manage and ensure the...SeniorRegulatoryContract workLocal area$180k - $230k
Mix Talent is seeking an Associate Director / Director for Quality Assurance in Milpitas, California. This hands-on leader will oversee daily QA operations, ensuring compliance and operational excellence in a contract manufacturing setting. Key responsibilities include...SeniorFull timeContract work$200k - $225k
...Permanent - Newark, California Lead quality with confidence-shape the future of... ...Proclinical is seeking an Associate Director of GMP Quality Assurance to support CMC operations in California... ..., providing guidance on regulatory requirements and ensuring compliance...RegulatoryPermanent employment- ...-line, and our team is passionate about quality craftsmanship. Job Description The Quality... ..., company quality standards, and regulatory requirements. This position provides daily... ...Engineering, Supply Chain, and Quality Assurance to drive product quality and continuous...RegulatoryContract workWork at officeMonday to FridayShift work
- ...thousands of systems worldwide. Increasing quality, reliability, safety, and security needs... ...expectations. This role leads quality assurance activities across manufacturing, supply... ...satisfaction. Ensure compliance with customer, regulatory, and industry quality requirements....RegulatoryContract workWork at officeWorldwide
- ...Job Title: Quality Operations Manager Job Description: The Operations Quality Manager will... ...corporate goals and compliance with all regulatory requirements for Philips' Image Guided... ...executing recall procedures, producing quality assurance deliverables, and fostering...RegulatoryFull timeWork at officeWork visaRelocation package3 days per week
$180k - $230k
Associate Director / Director, Quality Assurance Position Summary The Associate Director / Director, Quality Assurance is a hands‑on quality leader... ...quality representative and front‑room lead for all regulatory and client audits and inspections, including FDA, EU, and...RegulatoryFull timeContract work$135.5k - $216.8k
...around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient... ...training updates, etc. Assists with NB, Corporate and other regulatory, external, and internal audit readiness. Assist with execution...SeniorRegulatoryHourly payFull timeWorldwideShift work$27.35 - $35.56 per hour
...Services (FSS) Program, the Early Childhood Quality Assurance Coordinator, provides programmatic,... ...standards, grant requirements, regulatory expectations, and accreditation requirements... ..., process improvements, and strategies that enhance program effectiveness and...RegulatoryHourly payFull timeWork at officeMonday to FridayFlexible hours$112k - $154k
...more than just a job—you will find purpose and pride. As the Quality Assurance Manager at Baxter you will be responsible for Day-to-day... ...and release activities. Interfaces with regulators during regulatory inspections/ audits. Identifies, manages and drives continuous...RegulatoryTemporary workLocal areaWork visaFlexible hours$191k - $202k
...Head Of Quality Assurance We are seeking a Head of Quality Assurance to join Aspect's technical operations team. Reporting to the Chief... ...inspection readiness activities and host internal, vendor, and regulatory agency inspections (FDA, EMA, Health Canada). Lead...RegulatoryLocal area$125k - $135k
...years. Job Description The Senior Scientist, Analytical Development... ...the highest standards of quality, documentation, compliance, and... ..., data integrity, and regulatory compliance. Maintain accurate... ...recommendations, and assay development strategies to clients, internal...SeniorRegulatoryFull timeContract workMonday to Friday$112k - $264k
...a Product Manager for Factory Software Quality Systems. The Factory Software team is responsible... ...Define and execute the product vision, strategy, and roadmap to enhance and optimize... ...to adapt workflows to diverse regulatory and market requirements without sacrificing...RegulatoryHourly payFull timeTemporary workFlexible hours$225k - $250k
...Senior Director, Corporate Strategy Join to apply for the Senior Director, Corporate Strategy role at Fiery Fiery LLC is a leading provider... ...fast performance, stunning colour, and exceptional print quality across a broad range of production printing devices....SeniorFull time- ...Quality Engineering Manager Unigen, headquartered in Newark, California, is a trusted partner for businesses seeking to power their... ...initiatives to ensure products consistently meet customer, regulatory, and company requirements. The Quality Engineering Manager serves...RegulatoryFull time
$114k
...Summary Provides scientific and technical, support to the Quality Control Technical Service group while coordinating all aspects... ...stability program. Conducts cGMP pharmaceutical testing to ensure regulatory compliance and safety. Assists in method transfers,...SeniorRegulatoryFull time$169.22k - $253k
Position Summary The Director, Global Product Quality - Manufacturing Product Quality... ...controlled way in accordance with regulatory expectations and... ...escalates quality issues to senior management when appropriate... ...key Otsuka projects to assure that goals set by the team...RegulatoryContract workTemporary workLocal areaFlexible hours- ...Allogene is seeking an Associate Director of External Quality to provide quality... ...CMC Program Management to assure on time delivery of approved... ...preparation of relevant sections of regulatory submissions and response... ...project status updates to senior/executive management as...RegulatoryFull timeContract workLocal area
$159k
...Category: Business Operations / Strategy Job Level: Senior Manager Business Unit:... ...and external/internal regulatory requirements. It partners... ...senior leaders; preparing high-quality executive presentations;... ...of a manager or director Ability to analyze complex...SeniorRegulatoryContract workWork experience placementWork at officeFlexible hours2 days per week3 days per week- ...This role is a core senior financial position within... ...company’s financial strategy, accounting and tax compliance... ...to the Board of Directors and executive... ...regulations, and applicable regulatory requirements. Develop... ...continuously enhance governance quality and capital market...SeniorRegulatoryFlexible hours
$110k - $140k
...Job Title: Senior Business Development Manager - US West Coast... ...~ Develop and execute strategies to expand Paragon’s presence... ...audiences (scientists, lab directors, R&D leaders, CTOs, procurement... ...competitive intelligence, and regulatory insight from the West Coast...SeniorRegulatoryFull timeContract workLocal areaFlexible hours- ...Abbott Laboratories in Pleasanton, CA is seeking a Senior Regulatory Affairs Specialist for Heart Failure. On-site role focusing on global regulatory strategy, submissions, and compliance. You will coordinate licenses and listings, interact with regulators, and support...SeniorRegulatory
- ...Senior Project Manager (Consultant) Location: Newark, CA (Onsite 4... ...alignment with business objectives, regulatory requirements, timelines, budgets, and quality expectations. Experience with... ...and ensure appropriate mitigation strategies are identified and executed....SeniorRegulatoryContract workLocal area
- ...Management Reporting, and General Ledger (GL) Target Platform Strategies. The team has established a consolidated framework that creates... ...available for both internal financial reporting and external regulatory reporting purposes, consumed by both LOB stakeholders and corporate...SeniorRegulatoryWork at officeVisa sponsorship
$44.13 - $57.36 per hour
...Senior Risk Adjustment Coder The Senior Risk Adjustment Coder will perform code audits... ...will be involved with activities of quality assurance auditing and risk adjustment code... ...setting with demonstrated knowledge and of regulatory billing and coding guidelines. ~ Understanding...SeniorRegulatoryHourly payWork experience placementWork at officeLocal area- .... Job Description The Senior Quality Engineer, Medical Device External... ...and Product Quality Assurance group and reports to the Senior... ...defined specifications and regulatory requirements. Responsibilities... ...Product Quality Assurance strategy to support medical devices...SeniorRegulatoryFull timeContract workTemporary workLocal area
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