Full-Time Quality and Regulations Manager
Job Description
About BrainSightAI
BrainSightAI is a leading health-tech startup that is building tools to empower clinicians with an AI and 3D enabled view into the functional and structural architecture of the brain, based on non-invasive imaging modalities.
BrainSightAI is a platform that combines cutting edge science and technology, with strong research and design ethic to solve the most pressing problems in neurosurgical, neurological and psychiatric cases. We use sMRI, fMRI, DTI, and digital phenotyping as foundational technologies that are served through 3D visualization for clinicians to get fast and precise inputs for decision making.
VoxelBox is our fMRI preprocessing and standardization tool that accelerates the turnaround time on fMRI reports to under a day providing greater range of evidence to clinicians for basing their diagnostic and treatment decisions on.
We understand that ongoing research is critical to advancing the field. We offer services and clinical study tools in addition to our VoxelBox suite of tools as a service to neuroscience institutions and clinicians looking at extending their research through experienced technology partners in us.
Our promise to the medical community is that we build solutions that will help reduce the $16.3Tn disease load of neuro-psychiatric disorders in the world. Our promise to patients and caregivers is that we will lead the charge to de-stigmatize mental disorders and make mental well-being a priority by not just creating conversation, but by tangibly improving understanding.
Desired Qualifications
- Bachelor’s degree in engineering or science or medical-related field.
- Experience of 1-3 years in relevant positions in medical device organizations, professional services organizations, or in consultancies working on AI/ML Software as a Medical Device (SaMD) are highly preferred.
- Should have very strong knowledge on the process of product development and the quality systems required to ensure regulatory compliance.
- Effective problem solving skills, excellent documentation skills, strong attention to detail, structured and methodical.
- Must be able to work independently and have the ability to work with cross-functional teams.
- Proven track record in influencing key stakeholders to implement processes and/or drive change.
Requirements
- Must have working experience in dealing with Software as a Medical Device (SaMD).
- Quality Systems development, implementation, and training experience as per ISO 13485.
- Strong understanding of US FDA, EU MDR and other global laws and regulatory requirements.
- Sound knowledge of standards on ISO 14791, IEC 62304, IEC 82304, IEC 62366.
- Good understanding of privacy and security standards namely ISO 27001, HIPAA and GDPR.
- Basic knowledge on requirements of ISO 14155 and 21 CFR Part 11.
Responsibilities
- Develop and maintain BrainSightAI QMS and supporting procedures to adhere to ISO 13485, as well as those required by international, regional and national regulatory authorities and standards.
- Review changes to existing documents and SOP’s to define the requirements and develop product documentation for all related medical device standards and regulatory submissions.
- Provides support and consultation to leaderships in ongoing process improvement, process standardization and integration efforts on systems development, policies and procedures.
- Actively support and/or participates in management committees and cross functional team meetings to provide regulatory inputs to ensure quality and compliance are built into the company’s activities.
- Organize, manage and execute internal and external audits and provide support during sponsor audits and regulatory agency inspections.
How to Apply
Please register your interest in the position of quality and regulations manager here: https://www.brainsightai.com/quality-and-regulations-manager370 total views, 0 today