Quality and Regulations Manager

Research and Development

As a Quality and Regulations Manager you will

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.

Must have:

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.
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.

Bonus if you:

Are enthusiastic about all things neuroscience
We are a company that highly values the ability to communicate well. We all take turns at the blog roster, so writing experience and/or enthusiasm is appreciated
Our core values encourage empathy and innovation, you are gold if you share these

Time requirement:

Previous work experience: