Regulatory Affairs Specialist

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Job description

Job Title: Regulatory Affairs Specialist

Work Location/Type: Boulder, Colorado In-Person/Hybrid

Schedule: Full-time

Compensation: Annual Salary $75,338 - $98,800

About the 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 methods developed at Stanford University. 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, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth. Foresight Diagnostics is headquartered in Boulder, Colorado.

About the Role:

The Regulatory Affairs Specialist supports our product teams supporting new product development and lifecycle management. This position is responsible for supporting the product development and regulatory submissions for in vitro diagnostic devices containing both software and chemistry. This is a role that would suit an individual interested in developing a career as a regulatory professional and who has interest in supporting the development of in vitro diagnostics in the US or international regulatory space. This is a full-time position working standard business hours but may require the flexibility to work diverse schedules, including evenings, weekends, and holidays. This position reports to the Manager of Regulatory Affairs.

Responsibilities

• Support the preparation, submission, and maintenance of electronic/paper regulatory submissions according to applicable regulatory requirements and guidelines.

• Support the development and maintenance of technical files for In Vitro Diagnostic devices per local and global regulations.

• Provide regulatory input and guidance on US and global regulatory requirements throughout product development for in vitro diagnostics devices.

• Support cross-functional team in the application of relevant regulations and standards (e.g., IEC 62304, ISO 14971, ISO 13485).

• Work closely with R&D, Quality Assurance, Manufacturing, and Marketing teams to ensure regulatory requirements are integrated into the product development process.

• Evaluate updated regulatory requirements and help implement necessary adjustments to maintain compliance.

• Assess the acceptability of documents and product development activities for submission filing to comply with applicable regulations.

• Conduct gap analyses and audits to identify areas of non-compliance and recommend corrective actions.

• Support medical device reporting, post-market surveillance, and vigilance reporting per the regulations.

• Work closely with other Regulatory Affairs team members to develop processes and implement compliance standards as required by local/international regulatory requirements.

• Monitor and track the status of regulatory activities/projects and provide updates to leadership as needed.

Skills and Qualifications

• Bachelor's degree or equivalent, preferred.

• Excellent technical writing skills.

• Strong analytical skills, attention to detail, and the ability to interpret and apply regulatory requirements.

• Excellent communication and interpersonal skills, with the ability to work collaboratively in a cross-functional environment.

• Familiarity with medical device regulatory pathways and requirements.

• Ability to work independently on unfamiliar tasks or projects when necessary.

• Ability to understand and apply international standards relevant to in vitro diagnostics.

• Proficiency in Microsoft Office programs, such as Word, Excel, PowerPoint, and Outlook.

Physical Requirements: This position requires the ability to communicate verbally and in writing, to sit for long periods, stand, and walk, and to utilize basic office equipment including a computer, keyboard and mouse. The role works in a climate-controlled environment, primarily indoors.

This role is offering a salary between $75,338 - $98,800, and is eligible for equity offerings.

Foresight offers benefits including paid vacation, sick time, and parental leave (if applicable), alongside medical, dental, vision, life, disability coverage, flexible spending accounts, and a 401k with company match.

The application deadline for this position is October 15, 2024

You will be working on interesting problems with extremely high impact. We promote the professional development of our employees and will encourage upward mobility within the company for high performing employees.

Foresight Diagnostics is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

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