BrainCheck is the creator of the leading cognitive assessment and care management platform empowering physicians to deliver high-quality, personalized cognitive health care to patients everywhere. It is used by hundreds of primary care and neurology practices to address cognitive changes early and enable patients, caregivers, and clinicians to work together to implement personalized recommendations to preserve brain health and functional independence. Our dynamic team is based in Houston and Austin, Texas.
Compliance Officer
This is an opportunity to join a dynamic team as we grow our team and expand our capacity. The ideal candidate has worked in compliance and regulatory roles within the medical device space, is highly organized, and is comfortable with being a critical member among multiple teams within a company.
Location
Preferably Houston or Austin, Texas. Open for Remote Work
Expected Responsibilities
- Oversee, manage, and enforce all quality assurance standards and programs to assure company compliance
- Own and manage an eQMS for new and existing medical devices
- Maintain and revise controlled documentation including procedures and reports
- Lead key regulatory initiatives as they come
- Facilitate QMS processes and procedures across management teams
- Continually strengthen the company’s effort towards regulatory excellence
- Oversee internal and external audits
Minimum Qualities
- 3-5 years' experience with a medical device/medical technology company.
- Preferably at least 1 year with Software as a Medical Device (SaMD) or Software in Medical Device (SiMD) utilizing an agile environment
- Strong understanding of FDA CFR 21
- Familiarity with ISO 13485, ISO/IEC 27001, and IEC 62304:2006
- Ability to excel in a fast-paced startup environment
Bonus
- Knowledge and familiarity with clinical trials regulatory affairs
- Certified Quality Auditor (CQA)
- Familiarity with EU MDR
- Experience bringing a medical device to market
- Experience with SaaS or PaaS product development
What We Do
BrainCheck is transforming cognitive screening and care by focusing on clinicians who are on the front lines of identifying and treating cognitive health issues like dementia and Alzheimer's dementia. Our mission is to empower physicians to provide personalized, cognitive care at scale. To do so, we've built a comprehensive cognitive care platform that fits seamlessly into clinical workflows.
The BrainCheck® CORTEX platform enables objective, standardized cognitive assessment that can be administered either in a doctor's office or remotely in the comfort of one's home. When cognitive health issues are detected, BrainCheck enables clinicians to manage care and communicate with patients and family caregivers all in one place, with automated documentation to help ensure practices are getting compensated for their work.
Why Work With Us
BrainCheck's tools are helping physicians identify & provide treatment for cognitive health issues like dementia, earlier than ever.
The work we do at BrainCheck makes a meaningful impact on people's lives, and we care personally.
If you want mission-driven work and to be surrounded by incredibly bright minds come join us.
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