Job summary
Job post source
This job is directly from Subsense Inc.
Job overview
The Regulatory and Clinical Trials Lead at Subsense Inc. will pioneer regulatory strategy and clinical trial management for innovative brain-computer interface technology, impacting neurotechnology and patient care.
Responsibilities and impact
The role involves overseeing the regulatory department, establishing regulatory strategies and quality management systems, collaborating with cross-functional teams, managing clinical trials, interfacing with global regulatory agencies, qualifying manufacturing partners, and building and leading regulatory teams.
Compensation and benefits
The position offers a competitive salary and benefits package, professional development support, and a collaborative, inclusive company culture.
Experience and skills
Candidates must have expertise in FDA, EU, and global medical device regulations, ISO 13485 and FDA QMS systems, clinical trial design and management, industrial scale-up of medical devices, startup experience, team management, and an advanced degree with 6+ years relevant experience.
Career development
The company supports professional development and continuous learning opportunities within a dynamic and innovative environment.
Work environment and culture
Subsense Inc. offers a collaborative and inclusive culture focused on innovation and dynamic work environment.
Company information
Subsense Inc. specializes in nanotechnology solutions for brain-computer interfaces and neurodegenerative disease treatment, aiming to revolutionize neurotechnology with cutting-edge products.
Team overview
The candidate will work with a diverse, interdisciplinary team integrating hardware, software, nanoscience, data science, and regulatory expertise.
Job location and travel
The job is located in Palo Alto, USA, as a full-time position.
Unique job features
This role is unique for its leadership in regulatory strategy within a cutting-edge startup focused on brain-computer interface technology and neurotechnology innovation.
Company overview
Subsense Inc. is a company founded and led by Tetiana Aleksandrova, who serves as its CEO. The company focuses on creating innovative products designed to bring transformative changes, though specific details about its offerings or industry are not provided. Tetiana Aleksandrova's background includes education at the Moscow School of Management, which may contribute to her leadership and strategic vision for the company. Further details about Subsense Inc.'s operations, revenue model, or history are not available from the provided data.
How to land this job
Position your resume to highlight your expertise in FDA, EU, and global medical device regulations, emphasizing your experience in establishing and maintaining ISO 13485 and FDA compliant Quality Management Systems for complex devices.
Showcase your leadership skills by detailing your experience managing regulatory teams and collaborating cross-functionally with hardware, software, nanoscience, and data science experts to develop innovative Brain-Computer Interface technology.
Emphasize your track record in designing and managing clinical trials for high complexity medical devices, as well as your ability to interface with regulatory agencies worldwide and negotiate approvals.
Apply through multiple platforms including Subsense Inc.'s corporate careers page, LinkedIn, and other job boards where the role is listed to maximize your chances of visibility and consideration.
Connect with current employees in the regulatory or clinical divisions at Subsense Inc. on LinkedIn; initiate conversations by referencing recent company innovations in neurotechnology or by asking about their experience navigating regulatory challenges in early-stage startups.
Optimize your resume for ATS by incorporating keywords such as 'regulatory strategy,' 'clinical trials,' 'ISO 13485,' 'FDA compliance,' 'medical devices,' and 'team leadership' to ensure it passes automated screening effectively.
Leverage Jennie Johnson's Power Apply feature to automate tailored applications, identify multiple application channels, and find relevant LinkedIn contacts, allowing you to focus your energy on preparing for interviews and networking.
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