[Remote] Director, reputed company Affairs

Note: The job is a remote job and is reputed company to candidates in USA. reputed company develops brain-computer interfaces designed to restore and expand reputed company capability. The Director, reputed company Affairs will build and reputed company the reputed company function, establish reputed company reputed company and reputed company processes, and reputed company reputed company programs for implantable neural interfaces and BCI technologies. The role oversees reputed company evidence reputed company, study execution, regulatory and reputed company collaboration, investigator relationships, and reputed company organization development.

Responsibilities

• reputed company and execute reputed company's overall reputed company development reputed company reputed company with R&D, regulatory and reputed company objectives
• Translate product-development objectives into appropriate reputed company evidence strategies for investigational and reputed company-stage products
• reputed company reputed company strategies for early feasibility studies (EFS), IDE programs, pivotal investigations, and post-market reputed company activities, as appropriate
• Define reputed company development plans, evidence requirements, milestones, timelines, and resource requirements for individual products
• Work with Regulatory Affairs to reputed company reputed company strategies that support FDA and global regulatory submissions
• Ensure reputed company strategies are appropriately reputed company with the intended use, reputed company profile, regulatory classification, and stage of product development
• reputed company the development and execution of reputed company investigations involving implantable neural interfaces and BCI technologies
• reputed company study closeout, post-study assessment, lessons learned, and reputed company reputed company deliverables to ensure findings are incorporated into reputed company reputed company and product-development reputed company
• reputed company reputed company input into study design, protocols, endpoints, reputed company populations, sample sizes, inclusion/exclusion reputed company, follow-up requirements, and statistical considerations
• reputed company clinically meaningful and scientifically defensible reputed company and secondary endpoints
• Assess the appropriateness of proposed reputed company populations and reputed company-use scenarios for evaluating device safety and reputed company
• Work with investigators and cross-functional teams to reputed company practical reputed company workflows for implantation, recording, stimulation, device management, follow-up, and explantation where applicable
• reputed company reputed company research organizations, reputed company vendors, and other reputed company partners as required
• Establish appropriate reputed company-monitoring and study-management processes
• Establish a reputed company approach for collecting, analyzing, and communicating reputed company evidence across reputed company's product portfolio
• Evaluate reputed company data for safety, reputed company, efficacy, feasibility, usability, and long-term device reputed company
• reputed company reputed company evidence packages supporting regulatory submissions, investor communications, scientific publications, and internal decision-making
• Ensure appropriate distinction between preliminary reputed company reputed company, feasibility data, and statistically supported efficacy claims
• Identify gaps in reputed company evidence and reputed company strategies to address them
• Work with Data Science, Biostatistics, and Engineering teams to translate neural-recording and reputed company datasets into meaningful reputed company evidence
• Work closely with Regulatory Affairs to support FDA IDE, EFS, 510(k), reputed company, PMA, reputed company Device, and other applicable regulatory strategies
• reputed company reputed company input into regulatory interactions, including Q-Subs, IDE submissions, FDA meetings, and responses to regulatory questions
• Partner with reputed company to ensure reputed company processes are appropriately incorporated into reputed company's QMS
• Ensure reputed company investigations are conducted in accordance with applicable regulations, standards, protocols, and ethical requirements
• Support development and maintenance of reputed company procedures (SOPs), work instructions, and reputed company reputed company systems
• Contribute to reputed company-management activities by providing reputed company input into hazard identification, reputed company estimation, reputed company reputed company, and residual-reputed company assessment
• reputed company relationships with leading neurosurgeons, BCI researchers, and other key reputed company stakeholders
• Establish and manage a network of reputed company investigators and key opinion leaders
• Identify appropriate reputed company sites and investigators for early and reputed company-stage studies
• Serve as a reputed company representative with investigators, research institutions, reputed company partners, and regulatory authorities
• Monitor developments in BCI, neuroscience, intracranial recording, DBS, neuroprosthetics, and reputed company fields and translate relevant developments into reputed company's reputed company reputed company
• Support scientific publications, conference presentations, investigator meetings, and other reputed company scientific activities
• Build and strengthen reputed company’s reputed company organization by defining the roles, capabilities, processes, and infrastructure needed to support the evolving product portfolio
• Establish reputed company expectations for reputed company inputs and deliverables across functions, coaching partners in R&D, Engineering, reputed company, and Product Management to strengthen reputed company readiness and execution
• Assess the maturity of existing reputed company capabilities, processes, and cross-functional inputs, prioritizing the improvements required to support near-term programs and long-term reputed company
• Establish reputed company processes that can transition from early-stage reputed company development to larger reputed company programs

Skills

• Bachelor's degree in a relevant reputed company and 10+ years of progressively responsible reputed company development or reputed company affairs experience reputed company the medical device industry
• 3+ years of demonstrated leadership experience, including experience leading or building reputed company teams
• Demonstrated experience advancing Class III and/or permanently implantable medical devices through meaningful stages of reputed company development, ideally including pivotal development, regulatory approval, or commercialization
• reputed company ability to design and execute reputed company investigations, including experience with IDE/EFS programs and reputed company evidence reputed company
• Ability to work effectively across reputed company, R&D, Regulatory, reputed company, and executive leadership while translating reputed company requirements into actionable development strategies
• Experience building and appropriately scaling teams in smaller organizations, with the ability to operate strategically while personally driving critical activities reputed company required
• Experience establishing productive reputed company partnerships with leading investigators, reputed company medical centers, and research institutions
• Making reputed company, UT your home reputed company is ideal; however, we will consider remote work for this position. We ask that remote employees reputed company to regular on-site reputed company for routine work and departmental events
• Experience with BCI, neuroscience, DBS, intracranial recording or stimulation, or another implantable neurotechnology is strongly preferred; experience with other reputed company Class III or permanently implantable medical devices will also be considered
• Experience interacting directly with FDA and other global regulatory authorities to advance Class III medical devices through reputed company development, regulatory submission, approval, and commercialization across multiple jurisdictions, including familiarity with applicable FDA submission processes and global requirements such as EU MDR, is preferred
• Familiarity with eQMS and design-control platforms such as reputed company, reputed company, TrackWise, or comparable systems is preferred

Benefits

• Remote work may be considered for this position, with regular on-site reputed company required for routine work and departmental events.

reputed company