Head of Quality and Regulatory

Whisper.ai is building the world’s first noise cancelling hearing aid system: it analyzes your audio in real time, automatically filtering out noise and amplifying the sounds you want to hear. Unlike traditional hearing aids, which simply amplify everything in the room, Whisper amplifies the person you’re listening to based on millions of audio prints it learns over time so it’s able to pick out who you’re listening to, even in the noisiest restaurant.

Based in San Francisco, Whisper is lucky to have the support of great investors including Sequoia Capital, First Round Capital, LUX Ventures, and more.

THE ROLE

Whisper is looking for our first Head of Quality and Regulatory to build a robust quality and regulatory program for our hearing system. In this role, you will manage all aspects of regulation and ensure the highest quality standards of our product. This role will touch all aspects of our product development cycle, thereby having an outsized impact on the launch of our product and the success of our company.

RESPONSIBILITIES

• Build and maintain a robust Quality System:
• Develop and maintain SOPs and Work instructions and other quality documents.
• Design and manage approval processes.
• Participate in the new product development process by providing regulatory requirements.
• Manage the FDA inspection process, ISO 13485 and CE marking processes.
• Own and manage the document control process.
• Build a quality and regulatory team.
• Define and manage the software tools needed for Document Control, Complaint Handling, Design and Development (in partnership with the development team), Testing and Verification.
• Own and manage post market processes such as complaint handling, adverse event reporting, post market data analysis.
• Conduct and/or direct internal quality and supplier audits.
• Provide guidance on labeling and promotional materials.
• Own all other regulatory/quality processes as required by applicable standards and regulations.
• Partner with marketing, customer service, engineering, and management to ensure a compliant business.

MINIMUM QUALIFICATIONS

• A minimum of 10 years of quality and regulatory experience with medical devices; a strong quality background is a must.
• Experience with medical device software highly desired.
• Experience successfully working with the FDA.
• Experience successfully submitting for ISO 13485 certification.
• Understanding of FCC regulations and testing.
• A great attitude and ability to work with ambiguity and in a very fast-paced environment.
• Extremely strong work ethic.

BONUS POINTS

• Previous experience developing a medical quality system specifically in a startup environment.
• Past work on a wearable consumer electronics device.
• Prefer candidate with a scientific or technical background.

If you’re interested in technically fascinating work that directly helps 360MM+ people hear again – we’d love to hear from you.

Whisper.ai is an equal opportunity employer committed to a diverse workforce with an inclusive working environment for everyone to do their best work. We do not discriminate on the basis of race, ethnicity, religion, gender, gender identity, sexual orientation, age, marital status, veteran status, or disability status.