Regulatory Affairs Manager

11 hours ago

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Precision Neuroscience

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brain-computer interfaces • medical device • neuroscience • neurology • BCI

11 - 50

💰 $41M Series B on 2023-01

Description

• Precision is building a direct connection between the human brain and computers, to benefit the hundreds of millions of people worldwide suffering from neurological conditions. • Established in 2021, we are a leader in the development and commercialization of brain–computer interfaces (BCI). • As a Precision employee, you will be collaborating with experts across a diverse array of fields–including neurosurgery, mechanical engineering, machine learning, and microfabrication–to push the boundaries of what is possible. • [...] • We are seeking a Regulatory Affairs Manager – Software to develop and implement regulatory strategies to ensure FDA compliance and approval for AI/ML algorithms.

Requirements

• A minimum of 7 years’ medical device industry experience is necessary with a strong focus on FDA and software (SaMD, AI/ML) • Proven track record of successful regulatory submissions and approvals for AI-driven medical technologies • Experience in working with Class II or III devices required • Excellent written and verbal communication and negotiation skills, with the ability to interact effectively with regulatory authorities and cross-functional teams • Knowledge of and experience in manufacturing medical devices in conformance with Quality System Regulation and ISO 13485 requirements. • Proficiency with medical device software development life cycles • Ability to focus on and achieve scheduled milestones, including contingency planning • Strong knowledge and understanding of FDA regulations (21 CFR 820), ISO 13485, IEC 62304, ISO 14971, HIPAA • Strong team-working and communication skills. A drive to get the job done in the face of obstacles and time constraints, and a willingness to jump in wherever needed • Competent using office software including MS Word, Excel, Internet Explorer, PowerPoint, and Outlook • A minimum of a bachelor’s degree in engineering or science field is required