Manager, Regulatory Affairs
San Francisco /
Quality & Regulatory /
At Big Health, our purpose is to help millions back to good mental health.
We do this by creating digital therapeutics: Daylight™, for worry & anxiety, and Sleepio™, for poor sleep - fully automated cognitive and behavioral programs that are scalable and clinically validated. They combine the intimacy of the human voice, engaging animation, and clinically rigorous techniques to help people overcome their mental health challenges.
Big Health’s products are backed by 50 published clinical papers including 13 randomized controlled trials (RCTs), and are cited in leading clinical guidelines including the American College of Physicians and NICE.
Today, over 12 million people worldwide have reimbursed access to Big Health’s products, via leading employers in the US and the UK’s NHS.
This is a new role on our Quality & Regulatory team, reporting to our VP of Quality and Regulatory Affairs, where you’ll have the opportunity to help build a functional area from scratch, influence the total product life cycle, and even help shape the regulatory space for the digital therapeutics industry. Join us!
As the Manager of Regulatory Affairs at Big Health, you will:
- Support Software as Medical Device (SaMD) product development and commercialization by developing regulatory strategies in order to achieve clearance/approval in the US and EU markets
- Maintain a strong grasp of regulatory guidance and trends, ensuring that information is disseminated across the organization for effective decision making
- Plan, author and submit all documentation associated with EU and US product registrations for new and modified products
- Assess new projects or product changes for regulatory impact (including US FDA Class 2, Class 1, enforcement discretion products)
- Support the management of communications and relationships with regulatory agencies including internal and external negotiations
- Represent regulatory affairs on various cross-functional business or product development teams to provide regulatory input, guidance, and support including design verification, and validation strategies to support all the regulatory aspects of the product development lifecycle
- Ensure the accurate interpretation and implementation of all regulatory guidance and policies across the business from software deployment and clinical study plans to advertising and promotional materials review
In order to be successful in this role, you will need to have:
- Minimum 8 years experience in a regulated healthcare industry (software medical device experience preferred) with responsibility for regulatory affairs activities
- Strong knowledge of and experience with pre- and post-market medical device regulations, requirements and submissions, especially De Novo submissions, PMA, 510(k), IDE and EU Technical Files
- Strategic horsepower - able to outline sound regulatory strategy that is alignment with regulatory guidance and reflects business priorities
- Clear and effective verbal and written communication skills with diverse audiences and personnel
- Strong organization and time management skills, including the ability to prioritize multiple challenging project timelines in a fast-paced environment while ensuring collaboration, accuracy of submissions, and all deadlines are met
- Leadership across cross-functional groups in the development of relevant data to complete a regulatory submission
Life at Big Health:
- Be part of a team that includes clinical psychologists, software engineers, business leaders and even a former professional magician [shh… it’s a secret]
- Surround yourself with the smartest, most enthusiastic and dedicated people you’ll ever meet, but who listen well, learn from their mistakes and when things go wrong, generously pull together to help each other out
- Check out our values - they’re a living, breathing part of our culture
- Enjoy benefits including a generous vacation policy, professional development fund, flexible working locations and more.
- Competitive salary packages including stock options.
Because we are on a mission to bring millions back to good mental health, we believe it’s essential to reflect the diversity of those we intend to serve. We’re an equal opportunity employer dedicated to building a culturally and experientially diverse team that leads with empathy and respect. Additionally, we will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance.