Senior RA/QA Specialist

Woebot Health has physical offices in San Francisco, Boston and Dublin, Ireland. If you’re not currently based in one of our beautiful flagship cities, please inquire whether your position can be fully remote

Our vision is to make mental health radically accessible.

We are a team of innovators, experts and business builders who have come together to develop advanced technologies that can transform healthcare. 

We’re focused on addressing the vast, unmet need for improved engagement and outcomes in mental health with Woebot, a digital coach that helps people engage more deeply and continuously in their mental health. Woebot's breakthrough is its ability to form a human-level bond with people using the latest in NLP, ML and other advanced technologies. Leveraging this therapeutic bond, and the expertise of our Stanford-trained clinicians and scientists, Woebot is constantly learning from the experience of more than one million people and hundreds of millions of messages exchanged to deliver high quality CBT-based therapeutic tools that are psychologically related and responsive to a person’s dynamic state of health.

Our work to advance human-centered technology has attracted a lot of attention. Today we’ve amassed more mentions in the scientific literature than any other digital therapeutic company, and are regularly featured as the architects of a radically new approach to mental health. But we’ve only just begun. With the backing of some of the world’s most forward thinking investors and a new round of funding complete, we’re poised to redefine how people access mental health care. 

Are you ready to create a new future for mental health, for everyone? Let's do it together!

How You’ll Thrive

Within Your 1st month you will:

• Collaborate with cross-functional teams to establish and implement an FDA and ISO 13485-compliant Quality Management System
• Collaborate with cross-functional teams to establish and implement supporting ALM/eQMS tools
• Provide direct support for Quality/Regulatory operations such as Document Control, Complaint Management, Internal Audit, Management Review, CAPA, etc.

By Month 3 you will:

• Engage with product delivery teams to provide examples and guidance on SaMD design controls best practices.
• Provide Quality/Regulatory review of project design control documents and records.

Within 6 months you will:

• Provide assessments of the Regulatory classification of new products and changes to existing products.
• Provide Quality/Regulatory review of product claims and promotional/marketing materials.

Within Year 1 you will:

• Assists in the preparation of FDA 510(k) submissions and Pre-Submission meeting requests
• Participates in FDA meetings, conferences, industry groups and FDA recognized collaborative communities

Key Responsibilities 

• You will own and perform the work necessary to establish and operationalize Woebot health’s Quality and Regulatory functions.
• You will collaborate with cross-functional teams to establish and implement an FDA and ISO 13485-compliant Quality Management System.
• Your growth opportunity will be the chance to learn the Quality and Regulatory compliance factors specific to Woebot Health products.

Role Specific Competencies

• Required

  • 5 or more years of progressive medical device Quality/Regulatory experience
  • Deep knowledge of the FDA QSR and ISO 13485
  • Demonstrable experience in the areas of responsibility noted above
  • Strong interpersonal and communication skills, self-starter, organized, detailed

• Preferred

  • Experience in a regulated SaMD environment preferred
  • Advanced degree preferred

Our Core Values:

• Empathic: You’re a compassionate person and a team player motivated to understand others and help them be successful, too. You care as deeply for your colleagues as you do for our mission and our users.
• Self-aware: You possess a high level of emotional intelligence, which allows you to understand yourself and others, and to have a healthy emotional life in the workplace.
• Proactive & flexible:You are able to hit the ground running, you take responsibility for finding a way to get the job done. You learn as quickly as possible and sometimes do things outside the immediate scope of your work, giving it all you’ve got.
• Strong work-ethic: You’ve mastered healthy habits in your life that allow you to do great things. You exemplify dedication and commitment to coming up with very good results in your work and inspire others to do the same.
• Growth mindset: You believe abilities – like intelligence and talent – can be developed through dedication and hard work. You see failure as an opportunity to grow and welcome feedback as a pathway to your continued success.
• Humble: You recognize that you are one among many, and you hold a genuine desire to discover what other people can offer. You are intrigued by how others think, and how others feel differently from you. You lean into these moments with patience and  curiosity.

 Benefits 

• Competitive Salary
• Stock Options 
• Flexible PTO
• Health, Dental & Vision
• Healthy Snacks

Woebot is an equal opportunity employer and we deeply value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.