Regulatory Affairs Specialist

Bengaluru            ·         Full time

About the job

Role & Responsibilities

• Set industry-leading standards and benchmarks for regulatory excellence in healthcare AI software documentation
• Help regulators understand healthcare AI software development processes
• Develop and communicate a solid understanding of the Risks and benefits of medical imaging AI
• Set up, maintain and document quality management systems suited to the recently developed EU and US regulatory requirements
• Manage internal and external audits
• Keep up with rapidly evolving global market regulation on AI in medical imaging
• Liaise closely with clinical and R&D teams to ensure that products are cleared fast as they are developed

Ideal Candidate

• Demonstrated history of driving products from development through to regulatory approval (CE and US FDA)
• Experience with software devices or AI software
• Work experience of 2-4 years
• Familiarity with IEC 62304 and ISO 14971
• Exposure to MDR process for software devices
• Experience with FDA technical documentation
• Demonstrated ability to work with regulatory authorities to develop new regulatory processes in areas with few precedents or standards
• Technical undergraduate degree, advanced degree preferred

Please click here to apply.