Senior Director, Regulatory Operations & Compliance

Summary

Join Foresight Diagnostics, a molecular diagnostics company developing non-invasive cancer detection technologies, as their Senior Director, Regulatory Operations & Compliance. Lead and oversee regulatory compliance for the company's in vitro diagnostic devices, focusing on international product registrations. Support product development, quality system improvements, and compliance throughout the product lifecycle. Collaborate with cross-functional teams to ensure compliance with regulatory requirements and quality standards. Maintain up-to-date knowledge of evolving regulatory requirements and ensure timely implementation. Provide regulatory oversight to post-market surveillance activities. Educate stakeholders on regulatory requirements to ensure company-wide compliance. This is a full-time position offering a competitive salary, bonus, equity, and comprehensive benefits.

Requirements

• 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

Responsibilities

• 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

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
• We promote the professional development of our employees and will encourage upward mobility within the company for high performing employees