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Engineer who analyzes quality data, resolves CAPA issues, and ensures compliance with ISO 13485 and FDA 21CFR 820 for medical devices.
QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work…
Manages regulatory submissions and compliance for medical devices, preparing 510(k) notifications, EU MDR Technical Files, and international registrations while ensuring adherence to US, EU, and global regulations.
What we are looking for: Plans, organizes and implements strategies and activities required to procure regulatory approval for new and revised product lines. Coordinates and prepares regulatory submissions, including…
Union: Non-Union Number of Vacancies: 1 New or Replacement Position: New Site: 2400 Skymark Avenue, Mississauga Department: Quality and Regulatory Reports to: Regulatory Affairs Manager Salary Range: $85,000 - $115,000…
Job Purpose: The Change Control Continuous Improvement Manager is responsible for identifying, developing, and implementing process improvement initiatives within the Change Control and Document Revision functions.…
Principal Embedded Software Engineer Fluidic Controls & Instrumentation — BrainEx Platform Bexorg, Inc. On-site, New Haven, CT About Bexorg Bexorg is on a mission to move medicine forward by developing technologies…
Primary Function of Position The Senior Director, Japan RAQA, is responsible for leading and overseeing all aspects of Regulatory Affairs, Quality Assurance and Safety Control within the Japanese market. This critical…
Leads regulatory strategy and compliance for biotech/pharma products, managing submissions (IND, NDA) and liaising with agencies like the FDA.
Lead the Quality Assurance team for medical devices, ensuring compliance with ISO 13485, MDR, and FDA while managing product validations and risk processes.
Title: Facilities & Operations Support Technician Reports To : Operations Director Job Purpose: As the Facilities and Operations Support Technician, you will help keep the building, shop floor, and common areas…
What You’ll Do: Collaborate closely with Operations and cross-functional teams to ensure quality performance of products and processes Serve as the Quality representative on cross-functional teams to address key…
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.
ROLE OVERVIEW Job Title: Business Development Manager - Medical Devices Job Type: Permanent Location: UK Remote - Travelling will be involved within UK & Ireland Hours: 37.5 hours per week Salary: from £65,000…
Lead a QA team to maintain and improve Blueprint Genetics’ clinical lab and medical-device quality systems, ensuring ISO 15189, ISO 13485, IVDR and other regulatory compliance while driving continuous process improvement.
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.
Drive quality improvements by investigating product/process deviations, performing root-cause analysis, and implementing corrective actions to reduce customer complaints in a regulated healthcare manufacturing environment.
About Air Techniques, Inc . Founded in 1962, Air Techniques, Inc. set out to manufacture first-rate products for the dental industry. Over 64 years later, Air Techniques has grown from a small company into a successful…
Write and maintain technical documentation for fusion-energy systems, collaborating with engineers and scientists to create specs, manuals, and compliance docs under ISO standards.
Oversees medical-device quality systems, ensuring FDA 21 CFR 820 and ISO 13485 compliance, audits, CAPA, and training across two manufacturing sites.
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