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
- ...filters, cones, protective clothing and devices to obtain high-quality images with radiation exposure... ...consistent with standards; monitors medical equipment and promptly adjusts or reports... ...logs, in accordance with regulatory, hospital and departmental standards...QualityRegulatoryMedical deviceFull timeWork experience placementShift work
$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 placementSecond jobLocal areaMonday to FridayShift work- 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
- ...to, and maintain compliance to/with Cutera’s Quality Management System and maintains regulatory approval to market devices. Additionally, the individual is responsible for... ...for an ISO certified Technology Company (medical device or electronics devices preferred).Extensive...QualityRegulatoryMedical device
$212k - $228k
....comPosition: The Director, Quality Systems provides strategic leadership... ...systems that meet global regulatory requirements, support... ...tracking. Partner with functional leaders to ensure timely document... ...biologics, pharmaceuticals, medical devices, or combination products....QualityRegulatoryMedical device- ...ensure that our technologies meet global regulatory requirements while maintaining the high... ...with applicable regulatory and quality standards (e.g., FDA, ISO 13485) through... ...compliance within a regulated industry (medical device, pharmaceutical, or biotechnology preferred...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
- ...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
- ...The organization seeks a Medical Technologist to provide operational support... ...instrumentation in a medical device setting. You will apply QC/Westgard... ...validation protocols, IQCP, and regulatory standards to ensure compliance and quality across lab operations. Responsibilities...QualityRegulatoryMedical 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...QualityRegulatoryMedical deviceRemote job
- ...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
- Medicines360, a women’s health innovator, seeks a Director of Quality Assurance to lead QA and GXP programs. The role ensures compliance... ...and global standards, collaborating with Head of Quality and Regulatory Affairs and external partners. You will manage QMS, lead...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
- ...and development of embedded software for medical device systems. This role focuses on... ...performance software in compliance with regulatory standards, including ISO 62304.As a key... ...with cross-functional engineering and quality teams. Your work will directly support...QualityRegulatoryMedical device
- Eight Sleep is seeking a Director of Regulatory Affairs and Quality Assurance to lead risk management, regulatory strategy, and QA operations... ...and interfaces with regulators. A strong background in medical devices and FDA processes is essential for success. #J-18808-Ljbffr...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
- We're looking for an experienced Regulatory Affairs and Quality leader to build out and run the compliance backbone for a newly launched medical device organization. This person will own risk management strategy, lead the quality management system, and act as the company...QualityRegulatoryMedical device
- ...operational support for laboratory instrumentation in a medical device environment. Apply knowledge of QC/Westgard rules, CLSI validation protocols, IQCP, and regulatory standards. Assist with ensuring compliance and quality assurance in laboratory operations. Support...QualityRegulatoryMedical deviceRelocationNight shift
$173k - $225k
...Senior Product Security Manager with proven experience in the medical device industry. In this role, you will safeguard medical devices... ...development, product development, product management, and quality and regulatory teams to ensure that security is embedded across the...QualityRegulatoryMedical deviceFull timeShift work- ...support for laboratory instrumentation in a medical device environment. Responsibilities Utilize... ..., CLSI validation protocols, IQCP, and regulatory standards to ensure lab compliance and... ..., validation procedures, and quality control; ability to support instrumentation...QualityRegulatoryMedical deviceRelocationNight shift
$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$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$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$127k - $165k
...Responsibilities include:Developing and executing regulatory strategies for new and modified medical devices in line with business objectivesManage regulatory... ...SOPs to improve regulatory compliance within the Quality SystemMonitoring the impact of changing global regulations...QualityRegulatoryMedical deviceFull timeRemote 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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