Senior Specialist, International Regulatory Affairs

Job Title: Senior Specialist, International 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, International 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 international markets (e.g., Europe). 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 international 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 Manager of Regulatory Affairs.

What You Will Do

• Support the regulatory team in the preparation, submission, and maintenance of technical files and regulatory submissions according to applicable regulatory requirements and guidelines.

• Support and develop documents for clinical performance studies under IVDR

• Develop technical files for In Vitro Diagnostic devices CE-mark approval.

• Support the submission of clinical trial applications, clinical trial start-up, and maintenance of on-going global clinical trials.

• Acts as the main point of contact for Authorized Representative/Responsible Persons and competent health authorities as required.

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

• Conduct regulatory assessments to assist in the development of local, regional, and global regulatory projects (e.g., EU, UK, Australia, Asia/Pacific).

• Represent regulatory affairs on product development and lifecycle management project teams for global regulatory projects.

• Provide regulatory input and guidance on global regulatory requirements throughout product development for in vitro diagnostics involving both chemistry and software components.

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

• Continuously evaluate updated regulatory requirements and contribute to providing cross-functional teams guidance throughout the product lifecycle.

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

• Educate stakeholders on current and new regulatory requirements to ensure company-wide harmonized understanding throughout the product development lifecycle.

• Work closely with Quality Assurance to develop processes and implement compliance standards and regulatory requirements.

• Provide project updates to cross-functional core teams and management, such as when compliance gaps are identified or regulatory activities are delayed

What You Will Bring

• Minimum 5 years of industry experience.

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

• Experience with EU conformity assessments requiring Notified Body review or clinical performance studies under IVDR.

• 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.

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

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