Job Description
Job description: Our client is seeking an experienced R&D Quality Business Partner with strong expertise in diagnostics and combination products to join our Research & Development (R&D) Quality team. This role will play a critical part in defining and implementing an R&D-specific Quality Management System (QMS) that meets global regulatory requirements while enabling innovation, speed, and scientific excellence. The ideal candidate will bring a deep understanding of diagnostics, medical devices, and drug-device combination product regulations and will serve as a strategic partner to R&D functions.
Responsibilities: - Strategic Quality Partnership.
- Serve as a trusted advisor and Quality Business Partner to R&D teams across diagnostics, medical devices, and combination product development.
- Partner with scientists, clinical, regulatory, and technical functions to embed quality and compliance in R&D operations without stifling innovation.
- Quality Management System (QMS) Development
- Lead the design and implementation of a fit-for-purpose, R&D-specific QMS that aligns with global regulations (FDA, EMA, ISO 13485, ISO 14971, EU IVDR, and 21 CFR Parts 4, 11, 210/211, 820, etc.).
- Define phase-appropriate quality processes for early discovery, translational research, diagnostic development, and clinical integration.
- Develop SOPs, work instructions, and risk-based controls tailored to the unique needs of R&D.
- Diagnostics & Combination Products Expertise.
- Ensure quality oversight of diagnostic development and drug-device combination product programs.
- Interpret and apply evolving regulatory requirements specific to diagnostics and combination products.
- Support design controls, risk management, human factors, labeling, and investigational use processes in collaboration with cross-functional teams.
- Compliance & Risk Management.
- Provide quality input into vendor qualification, collaborations, and external partnerships.
- Training & Culture.
- Develop and deliver training programs to build R&D awareness of quality requirements.
- Champion a culture of quality, compliance, and continuous improvement across R&D.
Requirements: - Bachelor's or advanced degree in Life Sciences, Engineering, or related field; advanced degree preferred.
- 8+ years of experience in Quality, with at least 3 years in R&D Quality or early development settings.
- Deep knowledge of diagnostics (IVDs, laboratory-developed tests, digital diagnostics) and combination product regulations.
- Proven experience in establishing or enhancing R&D-focused QMS framework's understanding of global regulatory requirements: FDA, EMA, EU IVDR, ISO standards, and 21 CFR.
- Experience in drug-device combination products, diagnostic clinical studies, and risk management.
- Excellent collaboration, communication, and influencing skills with the ability to work across highly matrixed organizations.
- Demonstrated ability to balance compliance with innovation and agility in fast-paced R&D environments.
- R&D-specific Quality Management System (QMS).
- Diagnostics.
- Medical Device, Pharmaceutical, Combination Products.
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