Senior Specialist, Regulatory Affairs

Job Title: Senior Specialist, Regulatory Affairs

Location: Hybrid, Remote, or On-Site in Boulder, CO

About Our 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 Senior Specialist, Regulatory Affairs is the Regulatory Affairs representative and subject matter expert for our product teams supporting new product development and lifecycle management with a focus on domestic markets. 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 a regulatory professional who has experience focused on US regulatory requirements for IVDs and working with cross-functional teams during product development. This is a full-time position working standard business hours but may require the flexibility to work diverse schedules, including evenings, weekends, and occasional holidays. This position reports to the Senior Manager, Regulatory Affairs.

What You Will Do

• 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.

What You Will Bring

• Bachelor’s or Master’s degree in related field.

• Minimum 5 years of industry Regulatory Affairs experience.

• Experience with next generation sequencing in vitro diagnostics in highly regulated environments (e.g., US FDA, CAP/CLIA, IVDD/IVDR) .

• Excellent technical writing skills.

• Effective communicator; ability to convey messages in a logical and concise manner.

• 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.

• Experience interpreting and applying standards including ISO 13485, ISO 15189, ISO 14971, and IEC 62304.

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

• Experience with Software as a Medical Device or medical devices containing software (preferred).

Physical and Mental Requirements, Working Conditions

• Learn new tasks, remember processes, maintain focus, complete tasks independently, make timely decisions in the context of a workflow, ability to communicate with others, ability to complete tasks in situations that have a speed or productivity quota.

• Travel quarterly, or as business need requires to Boulder, CO.

• Sedentary work. Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects. Position requires close visual acuity for preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading.

Compensation and Benefits

This role is hiring at an annual salary of $105,000 - $138,000 and is eligible for bonus and 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.

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.