Director of Quality and Regulatory Affairs

2 weeks ago


Coralville, Iowa, United States VIDA Diagnostics Inc Full time
Join VIDA Diagnostics Inc as a Director of Quality and Regulatory Affairs

We are seeking a highly skilled and experienced Director of Quality and Regulatory Affairs to join our team at VIDA Diagnostics Inc. As a key member of our organization, you will play a critical role in ensuring the quality and regulatory compliance of our products and services.

Key Responsibilities:
  • Maintain and improve our quality management system and GCP processes to meet regulatory requirements.
  • Ensure all clinical trials and related activities comply with regulatory requirements and industry standards.
  • Develop and execute regulatory strategies that align with business objectives and product roadmaps.
  • Oversee supplier audits, software validation, periodic reviews, QMS/GCP training, CAPA, internal audits, document control, technical writing, and sustainability processes.
  • Participate in risk assessments and develop risk management strategies to mitigate potential hazards associated with SaMD products.
  • Serve as an internal resource for guiding the incorporation of GCP/ISO requirements into SDLC and clinical trial workflows.
  • Facilitate annual internal audits to ensure compliance with customer and regulatory requirements.
  • Serve as the primary point of contact for regulatory agencies, notified bodies, auditing organizations, customers, and other external stakeholders on quality-related matters.
  • Host external audits and inspections.
  • Influence the development of corrective action/preventive action (CAPA) projects to ensure effective issue containment and drive risk-based improvements.
  • Oversee a team of quality, regulatory, sustainability, and data privacy professionals, ensuring alignment with organizational goals and regulatory requirements.
  • Monitor and analyze quality performance metrics to identify trends, areas for improvement, and process optimization opportunities.
  • Stay informed about emerging trends, developments, and best practices in quality assurance and regulatory compliance within the medical device and clinical trial industries.
  • Create, evolve, approve, and provide feedback on GCP/ISO policies and SOPs.
  • Manage and ensure adherence to the department budget.
  • Maintain company ISO certifications and regulatory registrations.
Requirements:
  • Bachelor's degree in computer science, health science, biomedical engineering, or a related field. Advanced degree and certifications in regulatory affairs, quality management, and CCRP are preferred.
  • 10+ years of progressive experience in quality assurance and/or regulatory affairs in a highly regulated environment (Pharma, Medtech).
  • 5+ years in a leadership role overseeing, coaching, and mentoring high-performing teams.
  • In-depth knowledge of ICH E6, FDA Clinical Trial Imaging Endpoint Process Standards Guidance for Industry (2018), Part 11, EMA Guideline on computerized systems and electronic data in clinical trials, FDA QSR, ISO 13485, IEC 62304, and ISO.
  • Strong understanding of software development lifecycle (SDLC) methodologies and agile principles.
  • Excellent leadership, negotiation, and communication skills, with the ability to effectively collaborate with and influence regulatory authorities, customers, auditors, and cross-functional teams at all levels of the organization.
  • Demonstrative problem-solving abilities and a proactive, results-oriented mindset.

VIDA Diagnostics Inc is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, veterans status, age, or disability.



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