Global QA Director - Medical Devices & Compliance
RAPS Institute
Medicines360 is seeking a Director of Quality Assurance to provide strategic leadership for QA and GXP activities across the organization and affiliates. This role ensures compliance with US FDA regulations, ISO 13485, and global standards while guiding quality initiatives from development through post‑market. You will manage the Quality Management System, mentor QA staff, collaborate with regulatory, manufacturing, and suppliers, and drive continuous improvement. #J-18808-Ljbffr RAPS Institute
- Medicines360, a women’s health innovator, seeks a Director of Quality Assurance to lead QA and GXP programs. The role ensures compliance with US FDA, ISO 13485, and global standards, collaborating with Head of Quality and Regulatory Affairs and external partners. You will...Medical device
$265k - $331k
Revolution Medicines in San Francisco seeks an Executive Director of GCP QA to oversee the global GCP quality strategy and ensure compliance across clinical development programs. The candidate will lead a QA team, oversee vendor quality management, and engage with regulatory...Suggested- ...should have extensive experience in regulatory submissions for medical devices, particularly with FDA and international standards. Responsibilities include developing regulatory strategies, ensuring compliance, and mentoring regulatory talent. Candidates should possess a...Medical device
- Eight Sleep is seeking a Director of Regulatory Affairs and Quality... ..., regulatory strategy, and QA operations from our San... ...market surveillance, maintains compliance to ISO standards, and interfaces... .... A strong background in medical devices and FDA processes is essential...Medical 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...Medical device
- ...Position Title: Director of Quality Assurance... ...approved complex drug-device combination... ...Management System, QA personnel, and Quality... ..., ensuring compliance with US FDA regulations... ...regulations, ISO 13485, and global regulatory... ...systems for medical devices in development...Medical deviceFull timeContract workWork at officeLocal areaWorldwide
- ...leverage our Pod platform to detect medical conditions and to provide therapy. We are looking for a Director of Regulatory Affairs and... ...submissions Oversee compliance and documentation practices... ...quality functions for medical devices Successful track record of FDA...Medical deviceFlexible hoursNight shift
$245k - $280k
...biopharmaceutical company is seeking a Quality Assurance Director/Sr. Director to manage GVP compliance and quality assurance efforts. This hybrid role... ...provide strategic guidance, and ensure compliance with global PV regulations. The position offers competitive compensation...- Structure Therapeutics in South San Francisco is seeking a Senior Director of GMP Quality Assurance to lead the global GMP QA strategy, ensuring compliance and overseeing quality operations. The successful candidate will have over 15 years of experience in quality management...
- ...pulmonary detection tools to market globally by leading regulatory... ...product lifecycle. The Director owns the overall regulatory... ...market access while maintaining compliance with evolving requirements like... ..., Health Canada, PMDA) for medical device hardware and SaMD products,...Medical device
- ...deliveries to date, including blood, vaccines, medical supplies, food, and retail products. Our... ...governments, retailers, restaurants and global businesses who rely on us to save lives,... ..., robotics, autonomous systems, medical devices, or other highly regulated manufacturing...Medical deviceLong term contractContract workLocal areaWorldwide
- ...Summary:We are seeking an experienced Compliance and Validation Engineer to lead validation... ...to ensure that our technologies meet global regulatory requirements while maintaining... ...within a regulated industry (medical device, pharmaceutical, or biotechnology preferred...Medical device
- ...executing regulatory strategies to ensure compliance and successful product approvals. You... ...such as the FDA, EMA, and other global health authorities. Ensure regulatory... ...within the pharmaceutical, biotech, or medical device industries. ~ In-depth knowledge of regulatory...Medical deviceContract workWork at office
- Neuralink, located in South San Francisco, is seeking a Global Supply Manager to drive sourcing strategy and manage supplier performance... ...deep understanding of various components used in innovative medical devices. Candidates should have a background in supply chain...Medical deviceFull time
- BioTalent in San Francisco is seeking a Director of Medical Operations to lead manufacturing operations... .... You will partner with R&D, Clinical, QA/RA, and the executive team to ensure... ...will own manufacturing controls, oversee global manufacturing initiatives, drive design...Medical device
- Revolution Medicines is seeking a Senior leader to oversee Global Quality Systems Monitoring & Excellence, ensuring governance, compliance, and continuous improvement across the QMS at our Redwood City, CA headquarters. You will drive audit readiness, KPIs, and cross-functional...
$68k - $177k
Neuralink is seeking a Global Supply Manager in San Francisco, CA, to drive the commercial... ...suppliers essential to our cutting-edge devices. The role covers sourcing strategy, supplier... ...experience with sourcing in hardware or medical device environments. Competitive salary...Medical device- A leading medical device company is seeking a Sr. Quality Engineer based in San Francisco, California. This role is responsible for ensuring... ...audits, and providing technical support to teams to enhance product reliability and compliance. #J-18808-Ljbffr Verge MedicalMedical device
$186k - $233k
...signaling pathway. The Opportunity Lead the Global Quality Systems Monitoring & Excellence... ...to ensure effective governance, compliance, and continuous improvement across the... ...the biotechnology, pharmaceutical, or medical device industry, including people leadership....Medical deviceFull timeLocal area- ...that support research, manufacturing, and compliance in a rapidly evolving industry. The... ...the pharmaceutical, biotechnology, and medical device sectors. This will be a hybrid role.Key... ...ensuring compliance with GMP, FDA, EMA, and global standards.Integrate advanced...Medical device
$265k - $331k
...skilled and experienced Executive Director (ED) of Global Patient Safety (GPS) Quality and Compliance to join our dynamic team. The... ...management, Quality Assurance (QA), and maintenance of Good... ...Regulatory Affairs, Quality Assurance, Medical Affairs, and other departments...Full timeContract workLocal area$127k - $165k
...regulatory strategies for new and modified medical devices in line with business objectivesManage... ...design changes to maintain regulatory compliance for significant changesAuthor or revise... ...the impact of changing global regulations on submission strategies &...Medical deviceFull timeRemote work- ...Quality Management System, QA personnel, and quality initiatives... ...submissions Ensure GCP compliance, supplier qualification, and... ...maintaining Quality systems for medical devices in development and... ...partners and teams locally and globally across multiple time zones Ability...Medical deviceWork at office
- ...registrations and licensing requirements. Develop global regulatory strategies for new and... ...new and existing regulations (e.g., FDA Medical Device Regulations, EU-MDR). Independently identify and solve regulatory and compliance issues, escalating to senior management as...Medical device
- ...operational execution Ensure compliance with GCP, ICH, and ISO... ...compliance, investigational device documentation, and audit/inspection... ...Support communications with global regulatory authorities Oversee... ..., ICH guidelines, and global medical device regulatory frameworks...Medical device
$190k - $316k
...Neuralink We are creating devices that enable a bi‑directional... ...lead the company’s privacy and compliance program end‑to‑end. You will... ...program, and translate complex global obligations into clear... .... Privacy experience at a medical device company or high‑growth...Medical deviceFull timeTemporary workFlexible hours$163.4k - $322.1k
...design, and patient-centered solutions, both domestically and globally. We are looking for practitioners who will work alongside... ...organizations, from biotechnology firms to global big pharma to medical device companies, to drive business value through end-to-end delivery...Medical deviceLocal areaFlexible hours$198.7k - $391.6k
...design, and patient-centered solutions, both domestically and globally. We are looking for practitioners who will work alongside... ...organizations—from biotechnology firms to global big pharma to medical device companies—to drive business value through end-to-end delivery...Medical deviceLocal area- ...potential. Our award-winning products help our global community gain a deeper knowledge of... ...and knowledge of global trade compliance with the ability to integrate cost tradeoffs... ...in consumer electronics, medical device, consumer product, or similarly complex...Medical deviceContract workTemporary workWork at officeLocal areaRemote workFlexible hoursShift work
$223.2k - $260.4k
...cardiac muscle dysfunction. Director of Operational Excellence (OpEx... ..., reduce costs, and ensure compliance across planning, sourcing,... ...supply chain, manufacturing, medical device, or technical operations),... ...a fast‑paced, matrixed, and global environment. Competencies Strategic...Medical deviceContract work
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