Imagen is creating a world without diagnostic errors. Imagen’s initial focus is on building AI-based software that can detect clinically-meaningful pathologies within medical images. Imagen’s long-term vision is to keep patients healthy by delivering novel insights to support early disease identification and improved patient management across episodes of care.
Imagen is a team of leading clinicians and technologists from top organizations working side-by-side to create clinician-driven technology. Imagen’s clinical team is comprised of radiologists and surgeons from Mayo Clinic, Stanford Hospital, Hospital for Special Surgery, Memorial Hermann, Mount Sinai, Harborview Medical Center, and others. Imagen’s technical team is comprised of machine learning PhDs and engineers with experience building technology and products at leading companies, including Google, Facebook, and Dropbox.
Imagen is backed by some of the leading names in healthcare and technology. Imagen was founded in 2015 and is based in NYC.
This role has two key responsibilities.
First, this role is responsible for planning, directing and monitoring Quality Assurance (QA) activities to ensure that Imagen’s software products are developed and deployed in accordance with internal policies and procedures, government regulations and guidelines, and industry standards (e.g. CFR Parts 11 and 820, ISO 13485, and MDD 93/42/EEC). This role will initially be the only quality role within the organization. This role is responsible for building out the quality system, which will include diving deep into the details. Over time, this role will be responsible for building out and managing a quality team.
Second, this role is responsible for the regulatory affairs function and associated activities, including: device oversight, labeling, and regulatory submissions.
This role reports directly into the CEO.
- Establish and implement a Quality Management System that complies with domestic and international quality system requirements and guidelines.
- Administer employee training assignments related to QMS.
- Communicate compliance and quality risks to senior management.
- Ensure product compliance by performing product inspections, device history reviews, and product release authorization.
- Plan, prepare, execute and report on internal audits; support leadership team in response to external audits.
- Ensure efficient and effective completion of assigned CAPAs, audit responses and quality notifications.
- Maintain and ensure integrity of the Device Master Record, and Quality System documentation.
- Hire and manage a small team focused on supporting the quality system.
- Provide leadership in the development of strategies to manage new, changing, and existing regulatory requirements.
- Serve as company liaison to regulatory agencies.
Values, Abilities and Skills
- Passion for our mission and a commitment to make a positive impact on the world.
- Maniacal drive to master the details; unafraid of rolling up your sleeves to get the 'must dos' done.
- Process-orientation combined with the perfectionist tendencies that will drive continuous process improvement.
- Infectious commitment to achieving quality, and an ability to achieve that quality through others (via coaching, training, and collaboration).
- Ability to synthesize and communicate complex information.
- Thoughtful understanding of trade-offs and their implications.
- 10+ years experience in comparable Quality and Regulatory roles within a medical device company.
- Deep understanding of the details around Quality Management Systems, domestic and international quality system requirements and guidelines. In particular, expert knowledge and experience with 21 CFR Parts 11 and 820, and ISO 13485.
- Experience with computer system validation and software development life cycles; knowledge of imaging software applications is a bonus.
- Bonus points for experience working in companies building software products that are used by external entities and individuals.
- Extra bonus points for experience in a start-up or “start-up like” environments.