Senior Regulatory Affairs Specialist

Mountain View       ·       Full time

Description

We are seeking a Senior Regulatory Affairs Specialist to manage regulatory activities associated with the development of our medical device. This is an extraordinary opportunity to join our core team to help shape the future of our company.

In this role, with the support of our external regulatory consultants and our highly accomplished technical team, you will be responsible for planning and executing our regulatory submissions. Submissions will relate to hardware and software components of our brain-computer interface (BCI).

Your work will help advance our product to commercialization so that we can improve the lives of patients who live with neurological disorders in a matter of months and years, not decades.

This position may be based in our NYC or Mountain View office. We are unable to consider remote-based hires for this role.

Responsibilities:

• Plan and execute regulatory submissions, including clinical trial applications, IRB and IDE submissions, pre-submission inquiries, 510(k) and PMA applications.
• Work with leadership to refine our regulatory strategy and development goals.
• Conduct regulatory risk assessments and recommend developmental options.
• Monitor newly published FDA guidelines and international guidance documents. Complete post-market surveillance.
• Provide training on applicable requirements for staff, as required.

Requirements

• 5+ years’ experience in regulatory affairs positions within the medical device industry, including working with devices that incorporate hardware and software components.
• Deep expertise drafting and executing FDA submissions within the medical device industry, including working with devices that incorporate hardware and software components.
• Experience with clinical trial applications, IRB and IDE submissions, pre-submission inquiries, 510(k) and PMA applications, post-market surveillance, and regulatory audits.
• Extensive knowledge of regulatory requirements, including an understanding of current global and regional trends.
• Track record of obtaining clearance and approval from the FDA for medical devices.

Please click here to apply.