Director, Regulatory Affairs & Quality - Medical Devices
Sway
Eight Sleep is seeking a Director of Regulatory Affairs and Quality Assurance to lead risk management and oversee the quality management system. You’ll serve as primary liaison with regulatory agencies and collaborate closely with R&D, Clinical, and the executive team. The role is rooted in San Francisco. You’ll drive regulatory submissions, ensure compliance with ISO 13485 and ISO 14971, and shape the company’s path to FDA clearances while advancing patient safety and product quality. #J-18808-Ljbffr Sway
- ...to leverage our Pod platform to detect medical conditions and to provide therapy. We are looking for a Director of Regulatory Affairs and Quality Assurance to help build a business... ...experience in quality functions for medical devices ~ Successful track record of FDA...QualityMedical deviceFull timeImmediate startWorldwideFlexible hoursNight shift
- ...experienced and highly motivated Regulatory Manager to join our Regulatory Affairs team. In this role, you will be... ...internal teams, including clinical, quality, and product development.... ...the pharmaceutical, biotech, or medical device industries. ~ In-depth knowledge...QualityMedical deviceContract workWork at office
$127k - $165k
...include:Developing and executing regulatory strategies for new and modified medical devices in line with business... ...regulatory compliance within the Quality SystemMonitoring the impact of changing... ...minimum of US and/or EU regulatory affairs experience with a Bachelor’s...QualityMedical deviceFull timeRemote work- Heartflow is seeking a Senior Manager of Quality System and Regulatory Compliance to lead and mature its QMS across global markets, focusing on SaMD and SaaS aspects within the medical device space. You will guide regulatory submissions, audits, and continuous improvement...QualityMedical device
$127k - $165k
...include: Developing and executing regulatory strategies for new and modified medical devices in line with business objectives... ...compliance within the Quality System Monitoring the impact... ...minimum of US and/or EU regulatory affairs experience with a Bachelor's degree...QualityMedical deviceFull timeRemote work- ...location. Our team of medical clinicians, roboticists... ...The Role You’ll own the regulatory strategy and FDA-facing... ...clinical operations, and quality to land an autonomous Class III surgical device with the FDA. You Will... ...0+ years in regulatory affairs at medical device...QualityMedical devicePermanent employmentRemote work
- Medicines360 is seeking a Director of Quality Assurance to provide strategic leadership for QA and GXP activities across the organization... ...Quality Management System, mentor QA staff, collaborate with regulatory, manufacturing, and suppliers, and drive continuous...QualityMedical device
- EPM Scientific seeks a Quality Director to lead the Quality organization within a regulated medical device manufacturing environment. You... ...of the QMS, maintain global regulatory compliance, and drive continuous... ..., R&D, Regulatory Affairs, and Supply Chain to foster...QualityMedical device
$195k - $250k
...Heartflow is a medical technology company advancing the diagnosis and management... ...worldwide. As the Senior Manager of Quality System and Quality (Regulatory) Compliance , you are a pivotal... ...national and international medical device regulations, including FDA, ISO 1348...QualityMedical deviceFull timeWork experience placementLocal areaWorldwideRelocation- ...Job Description Job Description PURPOSE The Regulatory Program Manager is a medical device project management role responsible for planning, coordinating... ..., while partnering closely with Regulatory Affairs, Quality, Clinical, R&D, and Operations. The role is not the...QualityMedical device
$265k - $285k
...****@*****.*** include: Provides regulatory leadership in support of the development, registration,... ...with Clinical Development, Clinical Operations, Medical Affairs, CMC, and Quality to develop, coordinate, and implement global regulatory...Quality- Stevenson Search Partners is seeking a Quality Control Inspector for a medical device client in San Francisco, CA. The role focuses on inspecting incoming, in-process, and finished devices to ensure conformance with SOPs and specifications. The ideal candidate will have...QualityMedical device
- ...California seeks an experienced Design Assurance Engineer for orthopedic medical devices. The role focuses on EU MDR remediation, quality initiatives, DHF updates, risk management, and regulatory compliance across the device lifecycle. The ideal candidate will have 5-1...QualityMedical device
- ...Director of Regulatory Affairs | Job Description About ZBiotics At ZBiotics, we make genetically engineered probiotics that improve daily life.... ..., we believe it's our duty to set a high bar for product quality, safety, and transparency for others to follow. In 2019,...QualityDay shift
- A leading medical device company is seeking a Sr. Quality Engineer based in San Francisco, California. This role is responsible for ensuring that products and processes meet quality standards and regulatory requirements. The ideal candidate will have over 5 years of experience...QualityMedical device
- Our On-Demand Talent Solutions team is excited to announce that we are hiring a Quality Control Inspector on behalf of our valued client. This client a medical device company developing innovative, minimally invasive solutions for urologic conditions. Summary: The Quality...QualityMedical device
- ...Assurance Engineer Orthopedic Medical Devices Location: California... ...support EU MDR remediation and quality initiatives for orthopedic medical... ...compliance with global regulatory requirements throughout the... ...Collaborate with Regulatory Affairs, Clinical Affairs, Manufacturing...QualityMedical device
- ...A leading medical device company is seeking a Quality Electrical Development Engineer II in San Francisco, California. This role involves collaborating on product development, ensuring PCB function verification, and interfacing with other engineering teams on quality-related...QualityMedical device
- ...will define plaque ground truth, curate datasets, and partner with Clinical, Regulatory, and Quality teams to ensure robust validation and compliance. The role requires 10+ years in medical devices, hands-on plaque characterization, and demonstrated experience with FDA...QualityMedical device
- Mira, a San Francisco-based hormonal health company, seeks a Quality Systems Specialist to maintain the QMS, conduct product compliance... ...staff on SOPs. This role collaborates with R&D to support regulatory compliance and product development, and ensures audits across...QualityMedical deviceRemote job
- ...reliability. # Drive engineering rigor: testability, code quality, review standards, performance regression prevention, and release... ...for real-world systems: robotics, instrumentation, medical devices, or other complex distributed products. Strong Python and...QualityMedical deviceFull timeRemote work
- ...product design changes, and technology transfer within a regulated medical device manufacturing environment. This role will partner closely with R&D, Product Development, Manufacturing Engineering, Quality, and Operations teams to ensure products are designed for...QualityMedical device
$210k - $260k
...cells that resist exhaustion and have qualities of durable stemness in order to... ...South San Francisco, CA offices. The Director of Regulatory Affairs/Global Regulatory Lead (GRL) will be... ..., Translational Medicine, and Medical Affairs teams to align regulatory strategy...QualityTemporary workLocal area- ...Company with well know, high quality product lines has open territory. Surgical instruments and devices sold to hospital and ambulatory surgery centers. The company offers... ...* Minimum 2yrs Hospital/surgery center medical sales experience * A four(4) year degreeQualityMedical device
$160k - $180k
The Associate Director, IT Compliance is responsible for organising... ...activities, and regulatory compliance guidance for GxP... ...between IT, Information Security, Quality Assurance, Legal, Privacy, Business... ..., biotechnology, medical device, healthcare or life sciences...QualityMedical deviceContract workWorldwideFlexible hours- ...Vice President of Sales About the Company Innovative provider of high-quality ophthalmic solutions Industry Medical Devices Type Privately Held Founded 1976 Employees 201-500 About the Role The Company is seeking a Vice President of North...QualityMedical device
$101.2k - $126.5k
...segments like Industrial Quality & Research, Medical Technology, Consumer Markets... ...(DR) to oversee regulatory licensing and ensure full... ...distribution of prescription medical devices within licensed facilities... ...closely with Regulatory Affairs to apply for, maintain, and...QualityMedical deviceWork experience placement- ...position provides international regulatory leadership and is primarily... ...and registrations for medical devices outside the United States. The... ...Serve as the primary Regulatory Affairs contact for routine... ...stakeholders.Collaborate with Quality, R&D, Clinical, Manufacturing...QualityMedical device
- ...stable, revenue-generating Digital Health medical device company with a strong commercial... ...enabled portfolio, they are seeking a Regulatory Affairs Technical Lead to own and implement regulatory... ...closely with Product, Clinical, Quality, and Engineering teams to bring innovative...QualityMedical deviceImmediate start
- ...electronic signatures. Support internal audits and FDA/regulatory inspection readiness. Collaborate with IT, Quality Assurance, Business Process Owners, System... ...systems in pharmaceutical, biotechnology, medical device, or other regulated industries. Hands-on experience...QualityMedical device
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