Regulatory Affairs Specialist

About Qure.ai:

Qure.ai develops artificial intelligence enabled products and platforms for healthcare diagnostics. We have a talented team of data scientists, deep learning engineers, regulatory experts, commercial team and client managers. Founded in 2016, we apply the latest AI research to healthcare problems and develop innovative solutions that are revolutionizing the way patients are diagnosed and treated. Our solutions have impacted more than 4 million lives in 50 countries.

Qure is an equal opportunity employer. Artificial Intelligence technology evolves fast, and healthcare regulators are striving to keep up.

Job Description

As Regulatory Affairs Specialist , you will develop and execute strategies to bring this newly developed class of medical devices to market.

Your

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

Your Skills,

Qualifications , and Personal attributes

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 2-7 years

Familiarity with IEC 62304 and ISO 14+71

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

You will be part of a rapidly growing organization, with an opportunity to work alongside the best minds in the industry. Competitive compensation and rewards, opportunity to grow with a young company.

Location:

Mumbai

Inclusive workspace:

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