Senior Scientist

An opportunity is available for a Senior Scientist. This role focuses on leading complex research initiatives, managing Validation & Verification (V&V) studies to support PMA, 510K, and IVDR regulatory submissions, and fostering scientific innovation in a regulated design control environment. Responsibilities include managing project timelines, interpreting data, mentoring junior team members, and ensuring compliance with safety regulations when handling human biological specimens.

Key Responsibilities:

• Lead multiple project studies supporting regulatory submissions.
• Mentor and train junior scientists to promote scientific excellence.
• Conduct and document product development in accordance with design control and quality systems.
• Develop and optimize study protocols aligned with CLSI guidelines and regulatory standards.
• Perform and interpret complex statistical analyses, independently or in collaboration with statisticians.
• Prepare detailed study reports for regulatory submissions and scientific communications.
• Present research findings and project updates to internal and external stakeholders.
• Lead technical discussions and project meetings, aligning efforts with strategic objectives.
• Ensure adherence to biosafety and hazardous material handling procedures.