Almost every part of our daily life is now digital, from hailing a cab to paying a bill. But our medicines have not caught up. They're still stuck in an analog era. Propeller Health is on a mission to improve people's health by connecting the world's medicines. Our growing team enjoys working together to innovate new technology to address challenging problems whose solutions create enormous social value and improve patient health.
We aim to create beautifully invisible technology, accessible to all, that ensures people are free from the burden of chronic disease. Our medical devices are a combination of hardware sensors and software that digitally guides the course of therapy for patients and physicians managing respiratory disease.
Why This Job Is Important
Propeller's aim is to help as many people as possible live better lives. How do we balance developing medical device products in a consumer-facing world where technology changes constantly and people expect continual improvement? The quality and regulatory team is an integral part of the product development process. In this role, you'll lead regulatory and quality strategy for Propeller's software and hardware products. You'll develop regulatory submissions for Propeller's key markets and oversee compliance of the company's Quality Management System. And you'll manage the people and processes that make up our Hardware QA, Software QA, and Regulatory teams.
Consider Joining Us If You Are
- Eager to work at a fast-paced startup company on a small, but mighty regulatory team
- Passionate about eliminating waste, and getting stuff done
- Not afraid to experiment and fail. Failure is an opportunity to learn, and is embraced as a core tenet of Propeller
- Enjoy working on complex problems, and navigating subjective and often unclear regulations and guidelines
- Deeply enjoy and excel at managing, mentoring, and coaching people on a diverse, cross-functional team
- Naturally curious, and believe in lifelong personal growth
- Comfortable evaluating, understanding, and taking risks
- Comfortable with decisions being made at the individual level for by subject matter experts
- Driven by detail, persistent, and task-oriented
- An excellent communicator in written and face to face interactions
- Highly capable of leading and empowering teams and individuals
- Able to communicate regulatory requirements to key stakeholders
- A believer that technology can help solve hard problems and change the world
- Aware that technology, by itself, does not delight customers; the sweet spot is when we combine technology with practical solutions, surprises, utility, and social interaction
What You Will Do
You'll manage the Quality and Regulatory department and represent the team at meetings with key stakeholders. You'll oversee all internal and external customer audits and assist with the audit process. You'll work with the executive team on quality and regulatory deliverables, and be a strong advocate for the importance of regulatory compliance as a key consideration in major decisions. You'll analyze and develop regulatory strategy for international markets. You will work with your team to define and execute the overall strategy for quality and regulatory that builds on what we have today and creates a framework to continue to be at the leading edge of digital health software and hardware development. Perhaps most importantly, you are a very capable and empowering manager who will help the team and individuals to grow and excel in their functional roles and careers.
- Manage the preparation and execution of regulatory projects for all markets--the next two years will have particular focus on ex-US markets such as Japan and EU/UK.
- Assist partners in the diligence process for new projects
- Work with cross-functional teams to provide regulatory guidance through the interpretation of regulations, policies, procedures, guidelines, and compliance requirements
- Drive innovation in the QA testing of hardware and software products to improve test coverage, product quality and efficiency.
- Oversee and manage the hardware and software QA teams and regulatory project managers for US, Aisa, and the Americas.
- Maintain records of regulatory submissions, correspondence with legal/regulatory bodies, and other partners
- Serve as the Management Representative for quality on the Executive Team
- Oversee the company's Quality Management System
Experience We're Looking For
- Experience in medical device software
- Experience working with regulatory bodies regarding approvals, submissions, and all other communications, in the field of medical devices, digital therapeutics, or software
- Expertise with international regulations for Europe, Asia and the Americas
- Knowledge of Regulatory Compliance, specific to Quality systems, problem reporting, marketing, etc.
- Expertise with quality systems and standards including ISO13485
- Expertise with data privacy regulations including GDPR and HIPAA/HITRUST
- Bachelor's Degree in a related discipline
- 5-10 years of regulatory experience
- Additional Desired Certifications:
- RAC (Regulatory Affairs Certification) or other equivalent certifications
What We Are Not Looking For
- Analysis paralysis ⇒ Need to make decisions with what information we have or know how to get help
- Inflexibility in thinking ⇒ Creativity in this space is a must
- A top-down decision maker
What's In It For You
- You'll be a key decision maker for complex regulatory questions and learn first hand what it means to work with cutting-edge digital products.
- You'll deepen your ability to manage and grow a diverse team, including opportunities to be mentored in turn as a leader at Propeller.
- You'll collaborate regularly with a smart, creative team of professionals in a variety of roles. Solving respiratory disease requires a wide array of disciplines to work together. For example, we have epidemiologists, physicians/clinicians on staff combined with engineers, statisticians and data scientists to build the best respiratory solution possible.
- You'll have many opportunities to connect with your colleagues socially. We have regular summer cookouts for lunch, after-work events like board game and hobby night, and our annual company-wide camping trip! You can opt in wherever it makes sense for you.
- You'll be supported in balancing work with the rest of life. We encourage and support our team members to disconnect when they're not at work.
- You'll work in a beautiful office location in downtown Madison.
Propeller Health is proud to be an Equal Opportunity Employer. We are dedicated to building a diverse and inclusive team with a wide range of backgrounds and experiences, each helping us understand our patients better, and strengthen our team. We firmly believe that hiring and supporting a diverse team allows us to do the best work of our lives, and make the disease experience different. To do this, we strive to maximize access to every opportunity, cultivate a diverse set of candidates, and if hired, providing them with support, mentorship, and growth opportunities. We don't discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, ability status, or any other differences. Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records. All are welcome here.