Research and Development

Quality and Regulations Manager

Bengaluru, Karnataka, India

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.

Skill Set Required

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:  

 

  • Full-time

 

Previous work experience:

  • 2+ years