Overview
Remote
$35 - $45
Accepts corp to corp applications
Contract - W2
Contract - 6 Month(s)
Skills
Diagnostics
Combination Products
Job Details
Job Title: R&D Quality Partner Diagnostics & Combination Products
Job Location: Remote
Type: W2/C2C
Duration: 6 months (extensions possible)
Start Date: ASAP
Summary (Short JD):
Seeking an R&D Quality Business Partner with strong expertise in diagnostics, medical devices, and drug-device combination products. This role will define and implement an R&D-focused Quality Management System (QMS), ensure compliance with FDA, EMA, ISO 13485/14971, EU IVDR, and 21 CFR regulations, and act as a strategic partner to R&D teams. Must balance quality and compliance with innovation and agility in a fast-paced environment.
Key Skills:
- R&D Quality Management Systems (QMS)
- Diagnostics (IVDs, digital diagnostics, lab-developed tests)
- Combination Products & Medical Devices
- Global Regulatory Compliance (FDA, EMA, ISO, EU IVDR, 21 CFR)
- Risk Management & Design Controls
- SOP Development & Process Implementation
- Training, Quality Culture & Cross-functional Collaboration
Qualifications:
- Bachelor s or advanced degree in Life Sciences/Engineering (advanced preferred)
- 8+ years in Quality; 3+ years in R&D Quality or early development
- Strong knowledge of diagnostics and combination product regulations
- Proven track record in R&D QMS development and compliance oversight
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.