R&D Quality Business Partner

Company : Katalyst HealthCares & Life Sciences

Location : Jersey City, NJ, 07390

Posted Date : 13 October 2025

Job Details

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.