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Form of workTopography Health is a first-of-its-kind, physician-focused clinical trials platform. We offer a full stack of tools and services to empower doctors to gather evidence within an existing practice. Our mission is to accelerate clinical research by increasing the investigative capacity of every physician, creating a new world of medicine where patients have seamless access to advanced research. We care deeply about creating data sets that are more inclusive and representative, and we're determined to change how research is conducted at the community level. We're backed by Andreessen Horowitz, Bain Capital Ventures, and other great financial and strategic partners.
OVERVIEW
The Director of Quality, Regulatory, and Training, will play a pivotal role in ensuring our products and services meet the highest standards of Quality and compliance. You will lead the development, implementation, and continuous improvement of our quality management systems (QMS), regulatory strategies, and Training programs. As a subject matter expert, your expertise will guide our team in navigating the landscape of clinical trial regulations, ensuring our solutions are not only innovative but also compliant and efficient. You will be responsible for developing and managing talent within your team. The ideal candidate will possess exceptional communication and interpersonal skills, enabling effective collaboration across various departments, as well as with external partners. Candidates must possess a comprehensive knowledge and understanding of Trial Master File (TMF) management, including the handling, organization, and oversight of essential documents and records necessary for the conduct of clinical trials. This includes familiarity with regulatory requirements, industry standards, and best practices related to document management within a clinical trial setting. You should be a strategic thinker with a problem-solving mindset, adept at navigating the intricate regulatory landscapes associated with clinical trials, and comfortable serving as a point of escalation for the company.
KEY RESPONSIBILITIES
Develop and maintain a robust Quality Management System (QMS) that complies with applicable regulatory standards and industry best practices.
Lead regulatory strategy development and execution for the FDA and other regulatory bodies' submissions and interactions.
In conjunction with Legal and HR, manage all aspects of regulatory compliance, including document management, audits, inspections, and corrective and preventive actions (CAPA).
Design and implement comprehensive training programs for internal teams, ensuring understanding and adherence to quality and regulatory requirements.
Stay abreast of regulatory changes and trends in the clinical trials and SaaS industries, advising the leadership team on potential impacts and strategies.
Collaborate with product development teams to ensure regulatory considerations are integrated into product design and development processes.
Foster a culture of continuous improvement, leading initiatives to enhance efficiency, quality, and compliance across the organization.
Manage relationships with regulatory agencies, external partners, and vendors.
MINIMUM QUALIFICATIONS
Bachelor's Degree in a related field (e.g., Life Sciences, Regulatory Affairs, Quality Management)or equivalent 4 years of work experience
8 + years of experience in quality and regulatory roles within the clinical trials, pharmaceutical, or healthcare technology sectors.
8+ years of successful regulatory submissions and interactions with agencies such as the FDA
5+ years of experience leading a cross-functional team
5+ years of experience working with IRBs
Topography is an equal opportunity employer and does not discriminate based on race, age, religion, gender, gender identity, national origin, citizenship status, sexual orientation, disability, political affiliation, or belief. We are committed to creating an inclusive culture.
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