Regulatory & Quality Leader — Medical Devices
BioTalent
BioTalent is seeking an experienced Regulatory Affairs and Quality leader to build out the compliance backbone for a newly launched medical device organization. You will own risk management strategy, lead the quality management system, and serve as the primary liaison with regulators, collaborating with R&D, Clinical, and executive leadership to bring products to market and maintain approvals. Responsibilities include directing risk management strategy, leading regulatory submissions to achieve #J-18808-Ljbffr BioTalent
- ...industry. The Life Science Sector Leader is responsible for driving... ..., biotechnology, and medical device sectors. This will be a hybrid... ...standards, best practices, and quality benchmarks for life science... ...Monitor industry trends and regulatory changes to ensure compliance...QualityRegulatoryMedical device
- ...Francisco seeks a Senior Product Security Manager to safeguard medical devices by identifying and mitigating security risks across the... ...secure design reviews, collaborating with Product, R&D, Quality, Regulatory, and Cloud teams to embed security across PDLC and SDLC....QualityRegulatoryMedical device
- ...seeking a Senior Product Security Manager to safeguard medical devices by shaping a robust cybersecurity program across the product... ...lifecycle. You’ll partner with engineering, regulatory, privacy, and quality teams to translate risk into actionable requirements for...QualityRegulatoryMedical deviceRemote job
- ...- BRISBANE, CA, is seeking an International Regulatory Leader to secure and maintain regulatory approvals for medical devices outside the United States. You will develop strategies... ...global markets. You will collaborate with Quality, R&D, Manufacturing, and Commercial Sales to...QualityRegulatoryMedical device
$111k - $206.1k
...highly skilled professional, interested in Quality Excellence, driven by a passion for... ...critical Quality data to maintain full regulatory compliance while transforming raw metrics... ...Pharmacovigilance Practices [GVP], Medical Device Regulation [MDR], Software as a Medical...QualityRegulatoryMedical deviceLocal areaRelocation package- Verily Health is seeking a Quality Systems and Compliance Lead to own one or more QA domains... ...across consumer health, research tools, and medical devices. The role requires leadership of complex quality initiatives with regulatory impact. You will design, implement, and...QualityRegulatoryMedical device
$145.37k - $194.9k
...equitable and inclusive access to quality healthcare for its community... ..., protective clothing and devices to obtain high-quality images... ...with standards; monitors medical equipment and promptly adjusts... ...departmental logs, in accordance with regulatory, hospital and departmental...QualityRegulatoryMedical deviceFull timeWork experience placementLocal areaMonday to FridayShift work- ...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...QualityRegulatoryMedical device
- ...Summary:This position provides international regulatory leadership and is primarily responsible... ...approvals and registrations for medical devices outside the United States. The role develops... ...internal stakeholders.Collaborate with Quality, R&D, Clinical, Manufacturing,...QualityRegulatoryMedical device
- 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...QualityRegulatoryMedical device
- ...revenue-generating Digital Health medical device company with a strong... ...portfolio, they are seeking a Regulatory Affairs Technical Lead to... ...closely with Product, Clinical, Quality, and Engineering teams to... ...opportunity for a regulatory leader who wants to own strategy, influence...QualityRegulatoryMedical deviceImmediate start
- 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...QualityRegulatoryMedical deviceRemote job
- ...seeking an experienced and highly motivated Regulatory Manager to join our Regulatory Affairs... ...to internal teams, including clinical, quality, and product development. Monitor... ...within the pharmaceutical, biotech, or medical device industries. ~ In-depth knowledge of...QualityRegulatoryMedical deviceContract workWork at office
- 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....QualityRegulatoryMedical device
- ...Overview: We are seeking a detail-oriented Regulatory Associate to join our Regulatory... ...with internal teams, such as clinical, quality, and product development, to ensure alignment... ...within the pharmaceutical, biotech, or medical device industries. ~ Familiarity with...QualityRegulatoryMedical deviceContract workWork at office
- ...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...QualityRegulatoryMedical device
- EPM Scientific seeks a Quality Director to lead the Quality organization within a regulated medical device manufacturing environment. You will ensure the effectiveness of the QMS, maintain global regulatory compliance, and drive continuous improvement across development...QualityRegulatoryMedical device
- ...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...QualityRegulatoryMedical device
- 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...QualityRegulatoryMedical device
- ...: Design Assurance Engineer Orthopedic Medical Devices Location: California Duration: Long Term... ...to support EU MDR remediation and quality initiatives for orthopedic medical device... ...management, and ensuring compliance with global regulatory requirements throughout the product...QualityRegulatoryMedical device
- ...study timelines and ensure the quality and timeliness of data from... ...Central Reading Centers, Labs, Medical Coders). Author key documents... ...Managers, Programming, and Regulatory teams. Review study protocols... ...the pharmaceutical or medical device industry. Strong...QualityRegulatoryMedical device
- ...disabilities and improve their quality of life.Join a small,... ...evaluating custom Echo hardware devices and subsystems. The candidate... ...and hardware design through regulatory and test strategy inputDevelop... ...electromechanical class III medical device compliance testingExperience...QualityRegulatoryMedical device
- ...driven cardiac care with SaMD. As Principal Device Quality Engineer, you will be the global SME... ..., aligning Agile development with medical device regulations across the SDLC. Lead... ...control, risk management, V&V oversight, and regulatory submissions with FDA, PMDA, and EU-MDR;...QualityRegulatoryMedical device
$131k - $170k
...performance meets department production, quality, and operational standards. Performance... ...operational issues. Compliance & Regulatory Knowledge: Understanding of state and federal... ...operations management, preferably in medical device, healthcare services or clinical setting...QualityRegulatoryMedical deviceFull time$142k - $213k
...predictive, and precise. Description The Quality Systems and Compliance Lead drives... ...spanning consumer health, research tools, and medical devices are developed, commercialized, and... ...standards of quality, reliability, and regulatory compliance. Responsibilities Leads the...QualityRegulatoryMedical deviceFull time- Heartflow seeks a Principal Device Quality Engineer to serve as the global SME for software quality... ..., bridging Agile development with medical device regulations. You will ensure... ...analysis, V&V, and DHF management, and lead regulatory submissions with a collaborative, cross...QualityRegulatoryMedical device
$138k - $180k
...careerAbout This Role:A Senior Design Quality Engineer is responsible for supporting... ...processes, and all external design control and regulatory requirements.This position is hybrid... ...products with embedded software in the medical device field.Demonstrated competency of 21 CFR...QualityRegulatoryMedical deviceFull time2 days per week$112k - $134k
...clinical teams to transform patient care with devices supported by clinical evidence. It’s... ...Sales, Clinical Affairs, Marketing, Quality, Regulatory, and Education. After extensive... ...) years of experience previous related medical device, THV/TVAR, Cath Lab or clinical...QualityRegulatoryMedical deviceFull timeWork experience placement- ...of their location. Our team of medical clinicians, roboticists, and machine... .... The Role You’ll own the regulatory strategy and FDA-facing voice for... ...engineering, clinical operations, and quality to land an autonomous Class III surgical device with the FDA. You Will Strategy...QualityRegulatoryMedical devicePermanent employmentRemote work
- Responsibilities Act as a lead regulatory representative on core product development teams... ...and existing regulations (e.g., FDA Medical Device Regulations, EU-MDR). Independently identify... ...regulatory talent. Ensure US FDA Quality Management System (QMSR) requirements are...QualityRegulatoryMedical device
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