Job description
Job Title: Senior Director, Regulatory Operations & Compliance
Location: Remote, Hybrid, 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 Director, Regulatory Operations & Compliance is the regulatory representative and subject matter expert to lead and oversee regulatory compliance for the company’s pipeline of in vitro diagnostic devices particularly for supporting international product registrations with a focus on the US, UK, EU, Australia, and Asia/Pacific. This position is responsible for supporting the product development, quality system improvements, and compliance to regulatory requirements throughout the lifecycle of Foresight products. This is a role that would suit a regulatory professional who has extensive experience with developing and commercializing IVDs and ensuring compliance with international regulatory requirements. 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.
What You Will Do
Contribute to regulatory strategy of the Foresight products to ensure regulatory compliance requirements are met.
Collaborate with cross-functional teams to provide focused and directed guidance to ensure compliance to regulatory requirements and quality standards across all aspects of product lifecycle.
Work closely with quality assurance and other product development teams to enhance quality management system processes aligned with ISO 13485, FDA QSR (21 CFR Part 820), and IVDR requirements.
Partner with other regulatory affairs staff on the preparation, submission, and maintenance of technical files and regulatory submissions according to applicable regulatory requirements and guidelines.
Ensure compliance for in vitro diagnostic devices in clinical performance studies under IVDR (2017⁄746), GCP, and other international regulations and oversee the maintenance and updates of on-going clinical trials in international regions including US, EU, UK, Australia, and Asia/Pacific.
Act as subject matter expert to support quality audits from regulatory authorities, partners, or certification bodies.
Maintain up-to-date knowledge of evolving regulatory requirements for compliance and ensure timely implementation of new regulatory expectations within company processes.
Provide regulatory oversight to post-market surveillance activities, including complaint handling, vigilance reporting, and trend analysis in compliance with international regulatory requirements.
Review marketing materials to ensure compliance to applicable regulatory requirements of international regions.
Educate stakeholders on current and new regulatory requirements to ensure company-wide compliance.
Provide project updates to leadership such as when compliance gaps are identified or regulatory activities are delayed.
Other duties as assigned.
What You Will Bring
Candidate should have 7+ years’ experience in product, quality, and regulatory related to IVD medical devices.
A Master’s degree, PhD , or equivalent in a relevant field.
Extensive in-depth knowledge of global regulatory and quality frameworks for IVDs and medical devices including ISO, CAP/CLIA, CLEP, GCP, US FDA, EU IVDR (PRRC).
Deep understanding of regulatory and quality requirements for IVDs throughout the product lifecycle including clinical performance testing and post-market maintenance.
Proven ability to collaborate and influence diverse teams including multiple functional areas.
Direct experience partnering with Quality Assurance leadership to implement and manage process to ensure compliance to global regulatory requirements.
Experience applying and interpreting requirements of international standards including ISO 13485, ISO 15189, ISO 14971, IEC 62304, 21 C.F.R. 820.
Experience with next generation sequencing in vitro diagnostics in highly regulated environments (e.g., US FDA, CAP/CLIA, IVDR).
Experience with EU conformity assessments requiring Notified Body review and clinical performance studies under IVDR or MDR.
Effective communicator; ability to convey complex regulatory concepts in a logical and concise manner.
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.
Compensation & Benefits
This role is hiring at an annual salary of $235,000 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.
