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284 jobs
DHL
4 weeks ago

Quality & Regulatory Affairs Director

Open 25d LATAMContract
Mexico

About DHL Supply Chain: As the world’s largest contract logistics specialist, we create a competitive advantage for our customers by giving them logistics solutions based on our globally standardized warehousing,…

iso-13485 iso-9001 regulatory-compliance six-sigma solution-design +1 skills
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Alamar Biosciences
4 weeks ago

Senior Analyst, Quality Control

Open 33d North AmericaFull-timeSenior H-1B sponsor history — This employer has had H-1B petitions approved by USCIS in the last five fiscal years, per the USCIS H-1B Employer Data Hub. The approval belongs to the employer and is not a commitment to sponsor this role.
United States

Senior Analyst in Quality Control performs lab testing, data analysis, and process improvements for protein biomarker assays in a biotech company, ensuring compliance with ISO 13485/GMP standards.

iso-13485 process-improvement
90 000 – 100 000 $
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Veracyte
4 weeks ago

Manager Software Test Automation

Open 38d HybridNorth AmericaFull-time H-1B sponsor history — This employer has had H-1B petitions approved by USCIS in the last five fiscal years, per the USCIS H-1B Employer Data Hub. The approval belongs to the employer and is not a commitment to sponsor this role.
United States

At Veracyte, we offer exciting career opportunities for those interested in joining a pioneering team that is committed to transforming cancer care for patients across the globe. Working at Veracyte enables our…

ai api automation aws ccpa +30 skills
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clinchoice
4 weeks ago

Strategist, Regulatory Affairs

Open 26d North AmericaFull-time H-1B sponsor history — This employer has had H-1B petitions approved by USCIS in the last five fiscal years, per the USCIS H-1B Employer Data Hub. The approval belongs to the employer and is not a commitment to sponsor this role.
United States

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person…

iso-13485
ComplianceQuest
4 weeks ago

Sr. Product Manager

Open 26d RemoteNorth AmericaSenior H-1B sponsor history — This employer has had H-1B petitions approved by USCIS in the last five fiscal years, per the USCIS H-1B Employer Data Hub. The approval belongs to the employer and is not a commitment to sponsor this role.
United States

Define and ship cloud-based Quality Management System software for regulated industries like manufacturing, medical devices, and pharmaceuticals, using Salesforce and Agile practices.

adobe-xd agile ai as9100 cloud +15 skills
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comind
4 weeks ago

Verification Test Engineer

Open 26d On-siteUKFull-time
United Kingdom

Design and execute verification tests for a non-invasive neuromonitoring medical device, ensuring compliance with FDA and CE standards across hardware, software, and system levels.

ai automation firmware iso-13485 python +2 skills
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Ketryx
4 weeks ago

QA/RA Consultant

Open 76d HybridNorth AmericaFull-time
United States

Leads QMS implementations and regulatory compliance for medical device clients using an AI-powered platform, shaping future regulatory affairs strategies while ensuring high-quality standards for life-saving devices.

ai cybersecurity iso-13485 machine-learning regulatory-compliance
130 000 – 150 000 $
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Nova Pneuma
4 weeks ago

Director, Regulatory Affairs

Open 70d North AmericaFull-time
United States

Leads regulatory strategy and compliance for biotech/pharma products, managing submissions (IND, NDA) and liaising with agencies like the FDA.

iso-13485 regulatory-compliance
230 000 – 230 000 $
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Hartwig Medical Foundation
4 weeks ago

QA/RA Lead

Open 27d EuropeFull-timeLead
Netherlands

Lead quality and regulatory compliance for cancer diagnostics software, ensuring ISO 13485/15189/27001 adherence and EU MDR/IVDR regulatory strategy for SaMD/IVD products.

bioinformatics iso-13485 iso-27001 process-improvement regulatory-compliance
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Prolaio
4 weeks ago

Lead Software Quality Engineering, Backend

Open 79d North AmericaLead
United States

Lead backend test automation and validation for a cloud-based cardiology data platform, ensuring clinical safety and regulatory compliance while mentoring a small team of engineers.

analytics api automation bigquery cassandra +15 skills
150 000 – 150 000 $
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Veeva Systems
4 weeks ago

Clinical Compliance Operations Specialist

Open 27d RemoteEuropeFull-time H-1B sponsor history — This employer has had H-1B petitions approved by USCIS in the last five fiscal years, per the USCIS H-1B Employer Data Hub. The approval belongs to the employer and is not a commitment to sponsor this role.
Ireland

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed…

agile cloud gcp hipaa iso-13485 +6 skills
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Element Biosciences
last month

Global Support Engineer

Open 31d North AmericaFull-time H-1B sponsor history — This employer has had H-1B petitions approved by USCIS in the last five fiscal years, per the USCIS H-1B Employer Data Hub. The approval belongs to the employer and is not a commitment to sponsor this role.
United States

At Element Biosciences, we are passionate about our mission to empower the scientific community with more freedom and flexibility to accelerate our collective impact on humanity. We have built a highly efficient…

iso-13485 process-improvement
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whoop
last month

Regulatory Affairs Specialist II, Expansion

Open 31d On-siteNorth AmericaFull-time H-1B sponsor history — This employer has had H-1B petitions approved by USCIS in the last five fiscal years, per the USCIS H-1B Employer Data Hub. The approval belongs to the employer and is not a commitment to sponsor this role.
United States

At WHOOP, we're on a mission to unlock human performance and health span. WHOOP empowers its members to perform at a higher level through a deep understanding of their bodies and daily lives. WHOOP is looking for a…

cybersecurity iso-13485
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superellipse
last month

Electronics Design Engineer

Open 31d HybridEuropeContract
Belgium

Wie we zijn Superellipse is een zelfsturende design- en engineeringstudio. Al meer dan 30 jaar verleggen we samen met onze klanten de grenzen van innovatie. Ons team werkt nauw samen om gedurfde ideeën om te zetten in…

altium cpp firmware iso-13485 kicad +2 skills
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Blue Signal Search
last month

Manufacturing Transfer & Operations Manager (Raleigh, NC)

Open 32d On-siteNorth AmericaContract
United States

Manufacturing Transfer & Operations Manager Location: On-site in Raleigh, NC, with an initial 3-month deployment in Boise, Idaho An innovative and rapidly growing medical technology organization is preparing to…

automation iso-13485 iso-9001 stakeholder-management strategic-planning
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LINDERA GmbH
last month

Senior Machine Learning Engineer - AI Integration Engineer

Open 32d HybridEuropeSenior
Germany

Senior ML engineer builds and deploys computer-vision AI models for smartphone-based 3D motion analysis used in clinical diagnostics and orthopedics.

ai ci-cd computer-vision deep-learning devops +15 skills
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zoox
last month

Senior Quality Engineer, Advanced Hardware Manufacturing

Open 32d On-siteNorth AmericaFull-timeSenior H-1B sponsor history — This employer has had H-1B petitions approved by USCIS in the last five fiscal years, per the USCIS H-1B Employer Data Hub. The approval belongs to the employer and is not a commitment to sponsor this role.
United States

Senior Quality Engineer at Zoox in Fremont, CA, responsible for developing quality systems and processes for serialized production of sensor suites (LiDAR, camera, radar) in advanced hardware manufacturing, ensuring alignment with international standards like IATF 16949 and ISO 9001.

assembly iso-13485 iso-9001 jira lidar +2 skills
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Natera
last month

Design Transfer Scientist

Open 70d North America H-1B sponsor history — This employer has had H-1B petitions approved by USCIS in the last five fiscal years, per the USCIS H-1B Employer Data Hub. The approval belongs to the employer and is not a commitment to sponsor this role.
United States

Design Transfer Scientist at Natera to transition NGS-based IVD assays from R&D into clinical manufacturing, ensuring compliance and scalability while bridging lab work with production pipelines.

automation bioinformatics iso-13485 minitab statistics
116 160 – 145 200 $
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Natera
last month

Senior Scientist, R&D Design Transfer & Product Development

Open 69d North AmericaSenior H-1B sponsor history — This employer has had H-1B petitions approved by USCIS in the last five fiscal years, per the USCIS H-1B Employer Data Hub. The approval belongs to the employer and is not a commitment to sponsor this role.
United States

Leads the transfer of genetic testing assays from R&D to production, ensuring regulatory compliance and quality standards while collaborating across teams to validate processes and troubleshoot issues.

iso-13485
115 800 – 144 700 $
Natera
last month

Senior Manager, Operational Excellence and Process Engineering

Open 54d North AmericaSenior H-1B sponsor history — This employer has had H-1B petitions approved by USCIS in the last five fiscal years, per the USCIS H-1B Employer Data Hub. The approval belongs to the employer and is not a commitment to sponsor this role.
United States

Location: On-Site in Boulder, CO (Foresight Dx business unit, a Natera company) Foresight Diagnostics is a molecular diagnostics company pioneering non-invasive cancer detection through highly sensitive, cell-free…

automation bioinformatics iso-13485 performance-management
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