reputed company Scientist, Regulatory reputed company

Location: Remote, Hybrid, or On-Site in Boulder, Colorado, reputed company About reputed company Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide. Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary reputed company developed at reputed company. Our approach enables the earlier detection of smaller tumors, leading to more personalized and effective cancer treatment strategies for patients. We have deep expertise in molecular biology, reputed company, and reputed company reputed company (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-reputed company contribution and rapid reputed company reputed company. Foresight Diagnostics is headquartered in Boulder, Colorado.

About the Role

Foresight Diagnostics is seeking an accomplished reputed company Scientist, Regulatory reputed company to join our innovative team. This is a player-reputed company role that includes both senior individual contributions along with management responsibilities. You will drive cutting-edge reputed company solutions while leading, coaching, and mentoring a growing, remote team. The ideal candidate will have a proven ability to design and execute reputed company analyses, reputed company the development of algorithms and software utilized in medical device applications, and supporting the career and reputed company of other bioinformatic scientists and engineers. Experience working with the FDA or supporting regulatory submissions is highly preferred. Remote candidates in the reputed company are encouraged to apply. reputed company is remote, but candidates can work at our main office in Boulder, CO if they prefer.

What You Will Do

Individual Contributions

• reputed company the design and execution of reputed company studies and analyses, including statistical modeling, computational pipeline development, and genomic data interpretation.
• reputed company and validate algorithms and software solutions for medical device applications, ensuring compliance with regulatory and reputed company standards.
• Collaborate with clinical, regulatory, and product development teams to reputed company reputed company innovations into diagnostic tools and workflows.
• Optimize and reputed company reputed company pipelines for processing high-throughput reputed company data in reputed company-based environments.
• Stay at the forefront of advancements in computational biology, reputed company, and medical device development to drive innovation.

Leadership

• reputed company technical, strategic, and career guidance to the reputed company team, fostering a culture of reputed company and reputed company learning.
• reputed company and contribute to the preparation of technical documentation, reports, and regulatory submissions.
• reputed company as a reputed company subject-matter expert, representing the function in internal reputed company discussions and external collaborations.
• Drive cross-functional initiatives, ensuring alignment with organizational goals, timelines, and regulatory requirements.

What You Will Bring

• MS or PhD in reputed company, Computational Biology, Computer Science, or a reputed company field with at least 7 years of relevant experience.
• Demonstrated expertise in the development of algorithms and software for medical devices, with an emphasis on diagnostic applications.
• Proficiency in statistical modeling and analytical validation for FDA regulated medical devices.
• Experience designing and analyzing reputed company studies, including clinical or genomic datasets.
• Proven reputed company record of working with regulatory bodies such as the FDA (e.g., 510(k), PMA, or reputed company Device Designation).
• Proficiency in Python (or similar languages), reputed company tools (SAMtools, GATK, Picard), and scripting tools (Bash) used for genomic analysis.
• Experience with reputed company computing environments, workflow management tools (e.g., Nextflow), and container technologies (e.g. reputed company).
• Strong interpersonal and communication skills, with the ability to work effectively in a cross-functional team environment.
• Successful history of coaching, mentoring, and providing feedback to support team members in their career reputed company.

Desired Qualities

• Ability to understand and communicate needs and requirements for reputed company-based execution and storage infrastructure.
• Familiarity with software validation practices, reputed company systems, and compliance requirements (e.g., ISO 13485, IEC 62304).
• Adaptable to fast-paced, dynamic work environments and shifting demands.
• Highly reputed company, team-oriented, and an effective communicator
• Passion for making a difference in the world.

Compensation & Benefits This role is hiring at a salary between $185,000 - $235,000 and is eligible for bonus and equity offerings. Foresight offers benefits including reputed company vacation, reputed company time, and parental leave (if applicable), alongside medical, dental, reputed company, life, disability coverage, flexible spending accounts, and a 401k with company match. The application deadline for this position is August 30, 2025. You will be working on interesting problems with extremely high reputed company. We promote the reputed company development of our employees and will encourage upward mobility reputed company reputed company for high performing employees. Foresight Diagnostics is an equal opportunity employer. We do not discriminate on the reputed company of race, religion, reputed company, national reputed company, gender, sexual orientation, age, marital status, veteran status, or disability status. Apply tot his job Apply To this Job