Director Regulatory Affairs & Compliance

Bloomlife is a mission-driven company solving the most significant yet underserved challenges today in maternal health. We are designing the future of prenatal care to improve the health of moms and babies, through the most advanced combination of technology, medical expertise, and data science. You’ll join a top talent, fun, diverse, tight-knit team of experienced professionals who have worked in healthcare and technology across multiple functions. We think big and bold, and relentlessly execute.

You own regulatory affairs at Bloomlife with a primary focus on the US (FDA), and secondary focus on Europe (CE marking). You own and define the regulatory strategy (FDA and CE marking), including regulatory pathways, predicate selection, intended use definition, testing strategy, human factor validation and clinical validation. You’re hands-on and lead drafting of regulatory filings and technical files (FDA and CE marking) with input from the product, engineering, quality and clinical teams. You are the primary contact to the FDA and other regulatory authorities. You’re in charge of regulatory compliance for Bloomlife business and products, including 21CFR820, HIPAA, HITECH, cybersecurity. You work in close collaboration with product, engineering and algorithm leadership to ensure regulatory compliance across all aspects of the business and products.

Your responsibilities include:

• Define the regulatory strategy in alignment with business goals and product roadmap anchored in a deep understanding of Bloomlife products and the underlying technology, software stack, algorithm, human factors and clinical validation. You execute on the strategy and deliver regulatory submissions on time.
• Organize, lead, and manage regulatory filings for Bloomlife products. You define testing and validation requirements to fulfill regulatory needs. You weigh in on the human factor and clinical validation strategy to ensure pre-market and post-market evidence satisfy regulatory needs. You lead the redaction of technical files and contribute individually to writing the technical file with input from product and engineering.
• Communicate and interact with the FDA and other regulatory agencies; you establish a constructive relationship through regular touch points and pre-submission meetings to de-risk regulatory strategy and pathway.
• Define the compliance requirements for Bloomlife products and services in alignment with business and marketing goals. You execute on the compliance strategy by developing and implementing new SOPs, translating compliance requirements into product and engineering requirements, managing implementation in collaboration with product and engineering leadership, and obtaining the necessary certifications.
• You work with the marketing, clinical, product and engineering leadership to ensure regulatory compliance gets implemented across all layers of the organization and product. In particular, you ensure all product labeling and communication stay within regulatory and compliance guidelines.