Regulatory Affairs jobs in Italy

Seeking a highly motivated scientist to join the Molecular Diagnostics team, focusedon developing regulated diagnostic products and services, especially in genetic testing, andbased onmolecular approaches such as but not limited to next-generation sequencing (NGS)-based and nucleic acid amplification-based diagnostic assays.

The successful candidate will lead the development of innovative workflows for clinical applications and work closely with clinical and commercial stakeholders to deliver successful and impactful solutions.

• Responsible for good record-keeping and standard operating procedures (SOPs) implementation in accordance with confidential information requirement, quality system and regulatory guidelines.
• Responsible for mentoring junior scientists and coaching forthe latest technology development and product landscape.
• Responsible for prompt support and communicationwith internal and external collaborators.
• Responsible for assay planning andexecution.
• Responsible for presenting progress, findings, and providing solutions to internal and external stakeholders.
• Responsible for troubleshooting and keeping technical development timeline.
• Contribute to project scoping and preparing project proposals with in-depth understanding in clinical workflow, clinical unmet needs, technology value proposition, economic value capture, clinical deployment, and product commercialization pathway.
• Contribute to product landscape study on safety dossier and technical note approved by regulators.
• Contribute to clinical study design and clinical trial in regulated diagnostic product settings.
• Manage and perform lab operations activities, including general laboratory and equipment housekeeping and qualifications, and consumables purchasing.

• Education in Molecular Biology, Biochemistry, Genomics, Biotechnology, or a related field.
• 3-5 years of hands‑on experience in molecular assay development, preferably in industrial, diagnostics or clinical laboratory setting.
• Laboratory track record and skills in pre-analytical and analytical techniques, including extensive knowledge and hands‑on experience in molecular techniques.
• Strong track record in experimental design and optimisation of laboratory workflows.
• Familiarity with regulatory and quality standards for diagnostic assay development e.g. ISO13485.
• Ability to multi-task, while maintaining prompt response.
• Ability to articulate complex matters and simplify the matters.
• Great presentation skills for a mixed audience.
• Strong in identifyingcritical pathways and demonstrate problem‑solving abilities.
• Solid academic knowledge and a critical and innovative mindset.
• Extensiveindustrial relation and understanding of product landscapes.
• Optimistic and enthusiastic aboutcontinuous learning and professional development in the rapidly evolving field.
• A strong team player with a proactive and upbeat attitude.