Foresight Diagnostics Inc.
Regulatory Affairs Specialist
Foresight Diagnostics Inc., Boulder, Colorado, United States, 80301
Regulatory Affairs Specialist
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 Senior Manager of Regulatory Affairs. 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. 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. 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. 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. This position requires close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading. This role is hiring at an annual salary of $78,000 - $85,000 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. The application deadline for this position is July 30, 2025. 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.
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 Senior Manager of Regulatory Affairs. 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. 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. 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. 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. This position requires close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading. This role is hiring at an annual salary of $78,000 - $85,000 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. The application deadline for this position is July 30, 2025. 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.