At VIDA, were passionate about driving positive change in lung and respiratory care through thoughtful, innovative technology. Were committed to reshaping the way organizations and physicians approach pulmonary medicine with powerful artificial intelligence and image analysis. Our talented team works hard every day to design cutting-edge solutions that truly improve patients lives around the world. Were a small, fast-growing company with big benefits and the kind of culture that makes you smile. All were missing is YOU! If youre looking to make a difference and channel your expertise into meaningful work thats changing the world for the better, we want to hear from you!
As a Director, Quality & Regulatory you will have the opportunity to:
- Maintain and continually improve a comprehensive quality management system and set of GCP processes in accordance with regulatory requirements that apply to SaMD and clinical trial services (e.g. ICH E6, FDAs 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, ISO 14971)
- Leverage your GCP experience to ensure all clinical trials supported by VIDA and related activities comply with regulatory requirements and industry standards.
- Develop and execute regulatory strategies that align with business objectives and the product roadmap.
- Play a key role in developing strategies to balance protecting proprietary/confidential information with fulfilling customer and inspector requests for access to evidence of proof of adherence to GCP/ISO practices, while maintaining a fully compliant posture at all times.
- Oversee the supplier, audit trail review, software validation, periodic review, QMS/GCP training, CAPA, internal audit, document control, technical writing, and sustainability processes, among other processes that typically fall to the quality and regulatory department to oversee.
- Participate in routine risk assessments as part of the SDLC process and develop risk management strategies in collaboration with the risk management team to mitigate potential hazards associated with SaMD products.
- Serve as an internal resource for proactively 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 (information security, data privacy, customer requirements, GCP).
- 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 (customer, MDSAP/ISO, regulatory).
- Influence the development of corrective action/preventive action (CAPA) projects to ensure effective issue containment and to drive risk-based improvements that effectively optimize our processes, products, and services while preventing recurrence.
- 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 and drive changes in quality system and clinical trial processes to accommodate.
- Create, evolve, approve, provide feedback in relation to GCP/ISO policies and SOPs
- Manage and ensure adherence to the department budget.
- Maintain company ISO certifications and regulatory registrations.
Required Qualifications:
- Bachelors degree in computer science, health science, biomedical engineering or a related field. Advance degree and one or more certifications in regulatory affairs (e.g., RAC), quality management (ASQ Certified Quality Auditor) 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 and experience with ICH E6, FDAs 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, ISO 14971.
- 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.
Preferred Qualifications:
- Prior experience with SaMD products or digital health technologies is highly desirable.
All VIDA employees expected to be flexible and have an entrepreneurial mindset. ?Other duties may be assigned as needed.
VIDA 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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