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