R&D Project Manager - IVD

We are excited to present a rewarding opportunity for an experienced R&D Project Manager to join a leading organization in the molecular diagnostics sector. This role is critical in managing the development of PCR-based IVD tests, overseeing projects from conception to regulatory approval, and ensuring alignment with industry standards.

Key Responsibilities:

• Lead and manage development projects for molecular diagnostic PCR-based tests, ensuring timely execution from initial research to regulatory approval.
• Plan and oversee analytical and clinical performance evaluations, ensuring compliance with IVDR and other regulatory requirements.
• Coordinate method development, experimental design, and optimization of molecular diagnostic assays for point-of-care and point-of-need applications.
• Drive cross-functional collaboration, working closely with R&D, regulatory affairs, manufacturing, and commercial teams to align project objectives.
• Manage project timelines, budgets, and resource allocation, ensuring efficient progress and risk mitigation.
• Oversee documentation and reporting in compliance with regulatory standards and internal quality requirements.

Ideal Candidate:

• Educational Background: Advanced degree (MSc/PhD) in Molecular Biology, Biotechnology, Bioengineering, or a related field.
• Experience: Proven track record in managing R&D projects within the in-vitro diagnostics (IVD) or medical device sector, ideally in a regulated environment.
• Technical Expertise: Strong knowledge of RNA/DNA extraction & purification methods, molecular diagnostics, and PCR-based assay development.
• Project Management Skills: Ability to independently plan, execute, and oversee complex R&D projects, ensuring seamless coordination between teams.
• Regulatory & Compliance: Understanding of IVDR regulations, technical documentation, and validation processes for IVD products.
• Communication & Leadership: Excellent stakeholder management skills, with fluency in German and English.

Plus Points:

• Experience in the approval process of IVD medical devices and preparation of technical documentation.
• Knowledge of microfluidics applications in diagnostics.
• Expertise in primer and probe design and multiplex PCR assay development.
• Certification in Project Management (PMP, PRINCE2, or equivalent).

If this sounds like something you’d be interested in, I’d love to receive your application directly or feel free to reach out via email at jganiyu@barringtonjames.com.