Reports To: VP, Finance and HR
We are a profitable and growing software-as-a-service company headquartered in Rochester, NY and staffed nationally on a mission to transform and improve medical decisions through augmented thinking and timely visualization. Our vision is to become the most relied upon intelligence platform for improving medical decisions by healthcare professionals and lay people alike. We current serve more than 300+ enterprise customers and half of all medical schools in the U.S.
We’re looking for innovative problem solvers interested in developing programs and solutions that make a difference in people’s lives! Join us as we build and develop the people of VisualDx!
What You’ll Do
The Director of Quality and Regulatory Compliance is responsible for developing, implementing, and maintaining a Quality System as well as all matters that relate to regulatory compliance. This role is eligible for our work from anywhere policy.
- Develop, implement, and maintain a Quality System and regulatory compliance for applicable regulations (FDA/EMA, HITRUST, etc.), including Quality System documents as well as processes, systems, and activities related to a Quality System, such as CAPAs, deviations/clarifications, auditing, training, etc.
- Help the organization with the effort of achieving a HITRUST certification, including guiding departments through the interpretation of regulations and development of applicable documentation, reviewing the documentation to ensure that it has met the regulations, as well as guiding and training departments on best practices for performing activities, such as risk assessments, root cause analysis, etc.
- Provide guidance and examples to executive management, management, and staff on quality and compliance issues.
- Manage and perform the:
- Preparation, review, and approval of Quality System documents and associated records.
- Preparation and conduct of quality and compliance related training and associated records.
- Preparation, conduct/host, report writing, and follow-up of internal audits, vendor/supplier audits, customer audits, regulatory agency inspections, and associated records.
- Proactively participate in review and approval of products and/or services as part of the vendor/supplier management process.
- Lead the continuous improvement of quality and compliance.
- Stay current with proposed and current applicable regulations.
- Represent Quality and Regulatory Compliance in presentations to regulatory agencies as well as to current and prospective customers and vendors/suppliers.
- Other duties as assigned.
What You’ll Bring
- BA degree with a minimum of 5 years of relevant industry experience.
- Proven ability for process improvement, communication skills, and attention to detail.
- Ability to manage deliverables effectively across multiple departments.
- Working knowledge of:
- FDA/EMA, HITRUST/security, and other related regulations.
- Quality management theories and applications.
- Experience with FDA 510k classification process and Software as a Medical Device guidance.
- Regulatory experience working in a company that develops software solutions via Agile methodologies.
- Prolonged periods of sitting at a desk and working on a computer
- Must be able to lift 15 pounds at times
Why you’ll want to join VisualDx
Our people make VisualDx a great place to work. We’re connected through our mission to change medicine. VisualDx provides employees with work opportunities to stretch their minds and expand their skills. Here are a few other reasons you will want to join the VisualDx team:
We offer robust benefits, including:
- Health, dental, and vision insurance
- Contribution to 401k plan
- Paid time off: vacation, sick, and holidays
- Short- and long-term disability
We have fun. We host happy hours, picnics, holiday parties, catered lunches, and our newest tradition – Treat Yo’ Self Day!
We care. The Social Causes Committee, Wellness Wednesday, Diversity, Equity & Inclusion Committee, weekly yoga and meditation sessions nurture our mind, body, and soul and deepen our community connections.
We’re pet people! Dogs are common workplace companions in our headquarters and those working remotely share pet adventures via Slack.
We celebrate diversity and are committed to being an inclusive environment. We are an equal opportunity employer and do not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. Minorities are encouraged to apply.