Staff Engineer

Join Hinge Health as a Staff Regulatory Affairs Engineer and play a vital role in shaping the future of healthcare technology. In this key position, you will be responsible for ensuring our innovative solutions meet regulatory requirements, enabling us to deliver safe and effective products to our users.

Key Responsibilities: Provide essential administrative support to the Regulatory Affairs Department, ensuring thorough and timely evaluation of new regulatory information to assess its impact on Illumina products and processes. Additional Duties: Assist in scheduling major meetings for the Regulatory Affairs Department, managing expense tracking and submissions, as well as coordinating travel arrangements, purchase orders, and vendor creation. Core Responsibilities: • Collect, document, and maintain regulatory intelligence for both pre-market and post-market requirements across the US and international markets. Stay updated on new and revised regulations and communicate relevant updates to stakeholders. • Support the RA team by compiling and preparing both hardcopy and electronic submission packages for regulatory agencies. • Define, monitor, and receive deliverables related to submissions. • Draft and/or edit process documentation using existing RA templates or develop new templates to enhance continuous improvement within the Regulatory Affairs processes. • Execute other related tasks as assigned.All listed responsibilities are essential to this role; however, business conditions may necessitate reasonable adjustments to tasks and responsibilities.

Innovators Wanted Have you ever accomplished something that seemed impossible? If this thought excites you, keep reading! In 2015, we introduced a revolutionary approach to biotech, pooling innovative projects and promising early-stage research from academia under a single financial umbrella to mitigate risk and foster innovation. Our model empowers small teams of experts to lead groundbreaking advancements in rare diseases, developing transformative medicines for patients with unmet needs as swiftly as possible. We define new frontiers, challenge the status quo, and encourage individuals to solve complex problems. If you are someone who thrives on breaking conventions, join us and collaborate with some of the most esteemed minds in the biopharma industry. Together, we will ask, 'Why not?' and help reshape the future of healthcare. At BridgeBio, we embrace curiosity and innovation, including the ethical and thoughtful application of AI to enhance clarity, speed, and quality in our work. Key ResponsibilitiesAs the Vice President of Regulatory Affairs, you will lead BridgeBio’s operations and labeling functions while supporting regulatory strategy as needed. You will manage a team of experts handling Regulatory Operations, Regulatory Business Operations, and Labeling, ensuring excellence, compliance, and strategic alignment across all regulatory activities.You will ensure the organization possesses the necessary infrastructure, technology, and governance to facilitate global submissions and compliant labeling while integrating advanced capabilities such as artificial intelligence to enhance our processes.

Pinterest, Inc. is seeking a Senior Counsel, Regulatory Affairs to support its legal and compliance efforts. This role can be based in San Francisco, CA or performed remotely from anywhere in the United States. The work centers on regulatory compliance and legal guidance for a technology company known for its focus on user experience and innovation. Key Responsibilities Advise on regulatory matters that impact Pinterest’s business and products. Collaborate with cross-functional teams to identify and assess regulatory risks. Provide legal support for product initiatives and company operations. Help shape strategies to meet compliance requirements and address emerging challenges. Collaboration This position works closely with legal colleagues and teams across Pinterest, including product, policy, and operations. Strong communication and teamwork are important for success in this role. Location Candidates may work from San Francisco, CA or remotely within the United States.

HeartFlow, Inc. is a pioneering medical technology company dedicated to enhancing the diagnosis and management of coronary artery disease, which remains the leading cause of mortality globally. Utilizing state-of-the-art technology, our flagship product, the AI-powered HeartFlow FFRCT Analysis, is a non-invasive cardiac test that adheres to the ACC/AHA Chest Pain Guidelines. It generates a detailed, color-coded 3D representation of a patient’s coronary arteries, illustrating the effects of blockages on heart blood flow. As the first AI-driven, non-invasive, integrated heart care solution throughout the CCTA pathway, HeartFlow aids clinicians in identifying stenoses (RoadMap™ Analysis), evaluating coronary blood flow (FFRCT Analysis), and characterizing as well as quantifying coronary atherosclerosis (Plaque Analysis). With our expanding pipeline of innovative products, we invite you to join our mission to revolutionize precision heart care.HeartFlow is publicly traded (HTFL) and has garnered international acclaim for our healthcare innovations. Supported by medical societies globally, our solutions are cleared for use in the US, UK, Europe, Japan, and Canada, having positively impacted over 500,000 patients worldwide.The Senior Regulatory Affairs Specialist plays a crucial role in coordinating and supporting regulatory initiatives essential for the successful pre-market development, entry into new markets, and post-market activities for HeartFlow products.This individual contributor position is dedicated to providing exceptional regulatory support, ensuring compliance with relevant global regulations while adeptly navigating the dynamic regulatory landscape.The role encompasses activities related to regulatory approvals for marketing HeartFlow products, from development through post-market surveillance. The Specialist will assess device modifications for regulatory implications and formulate strategies for submissions and documentation management in alignment with the evolving global regulatory framework.Key Responsibilities:Regulatory Project ManagementAct as a representative for Regulatory Affairs on cross-functional teams to ensure regulatory alignment with business goals and timely submissions.Facilitate the creation of global regulatory strategies for HeartFlow products by collaborating with internal product teams and external partners including distributors and international regulatory teams.Review regulatory strategies with the Regulatory Affairs management team to ensure comprehensive coverage and compliance.

At Olema Oncology, we are committed to pioneering innovative treatments for breast cancer and other conditions. Our flagship program, palazestrant (OP-1250), is a cutting-edge complete estrogen receptor antagonist (CERAN), currently under development for metastatic breast cancer, and is poised to be a game-changing monotherapy and in combination with other therapies for ER+/HER2- metastatic breast cancer. Additionally, our next-generation candidate, OP-3136, is an advanced KAT6 inhibitor with the potential to set new standards in treatment.We believe that our scientific advancements are fueled by a culture of support, motivation, and challenge. At Olema, we prioritize our people, ensuring that our efforts lead to unparalleled outcomes. If you are ready to be part of a transformative journey impacting patients, your career, and the future of medicine, we want to hear from you!For more information, feel free to check out our latest corporate presentations here.About the Role: Senior Director, Global Regulatory Strategy Lead - Regulatory AffairsAs the Senior Director leading Global Regulatory Strategy in Regulatory Affairs and reporting to the Senior Vice President, you will take charge of:Driving the New Drug Application (NDA) process.Crafting and implementing innovative regulatory strategies to support Olema’s product portfolio.Serving as the regulatory subject matter expert on cross-functional teams, providing strategic guidance and oversight to global project teams, Study Execution Teams, and the Executive Committee.Leading the development of regulatory submissions (INDs, CTx, briefing documents, IB, NDA, BLA, DMF, IMPD, etc.) with both strategic and tactical insights.This position is based in either our Boston, MA or San Francisco, CA offices and may require up to 20% domestic and international travel.

Join Discord Inc. as a Senior Paralegal specializing in Litigation and Regulatory Affairs. You will play a pivotal role in supporting our legal team, ensuring compliance with various regulations and assisting in litigation processes. Your expertise will be essential in managing legal documents, conducting research, and collaborating with attorneys to navigate complex legal challenges.

Join Adyen as our Regulatory Licensing and Affairs Team Lead for North America, where you'll play a pivotal role in ensuring compliance and driving regulatory initiatives across a dynamic and fast-paced environment.In this position, you will lead a team of experts, fostering collaboration and innovation while navigating the complex landscape of financial regulations. Your strategic insights will influence our approach to licensing and regulatory affairs, making a significant impact on our business operations.

Innovators Needed Are you ready to take on challenges that seem insurmountable? If this excites you, continue reading. In 2015, we revolutionized the biotech landscape by adopting a “moneyball for biotech” model, uniting innovative projects and promising early-stage research under a single financial umbrella to mitigate risk and foster innovation. Our approach allows dedicated scientific minds and agile teams to drive groundbreaking advancements in rare diseases and create transformative therapies for patients with critical unmet needs at an unprecedented pace. At BridgeBio, we embrace curiosity and the thoughtful integration of AI to enhance clarity, speed, and quality in our work. Join us as we challenge the status quo, ask “why not?”, and reshape the future of biopharma alongside some of the brightest talents in the industry. Key Responsibilities#LI-TC1As the Senior Director / Executive Director of Regulatory Affairs, you will lead as a global regulatory expert with a focus on developing and executing regulatory strategies. Your role will include engaging with global health authorities, guiding cross-functional teams, and spearheading clinical and licensing submissions.Reporting to the Head of Regulatory Affairs, you will provide strategic leadership for regulatory activities related to assigned programs, including crafting global regulatory strategies, managing submissions, and overseeing pivotal interactions with health authorities while leading regulatory personnel.

Join Stripe as an Affiliate Services Licensing Specialist in our Regulatory Affairs team, where you will play a crucial role in ensuring compliance with licensing requirements across North America. This position offers an exciting opportunity to work in a dynamic environment focused on innovation and growth.

Join Intuitive Surgical, a leader in robotic-assisted surgical technology, as a Regulatory Affairs Specialist 3 for the Multiport da Vinci system. Your expertise will be crucial in navigating the complex regulatory landscape and ensuring compliance with FDA and international regulations.In this role, you will collaborate with cross-functional teams to support product development, regulatory submissions, and post-market surveillance activities. Your insights will help shape the future of surgical innovation, making a significant impact on patient outcomes.

Role overview The Regulatory Intelligence Specialist at Intuitive Surgical, Inc. will focus on tracking and interpreting regulatory changes worldwide that impact robotic-assisted surgical products. Based in San Francisco, this role plays a key part in keeping product teams informed and supporting compliance and market planning efforts. Key responsibilities Monitor and analyze trends and updates in regulations related to medical devices and surgical robotics. Interpret both new and existing guidelines, standards, and policies issued by regulatory authorities around the world. Summarize important findings and communicate them clearly to colleagues across different departments. Support product development and market access decisions by providing timely regulatory intelligence. Collaboration This specialist will work closely with internal teams, ensuring that regulatory insights are shared promptly to guide strategy and maintain compliance in a changing global landscape.

Join a dynamic team at Olema as the Associate Director of Global Regulatory Strategy - International. In this pivotal role, you will spearhead regulatory strategies across various global markets, ensuring compliance and facilitating successful product launches. Collaborate with cross-functional teams to navigate the complexities of international regulations and drive innovation in our product development.

Innovative Thinkers Wanted Have you ever accomplished what seemed impossible? If this idea excites you, continue reading!In 2015, we revolutionized the biotech landscape by adopting a pioneering approach that combines promising early-stage research from academia under one financial umbrella, minimizing risk and fostering innovation. This model empowers small teams of experts to drive scientific advancements. Our mission is to bridge gaps in rare disease treatment and rapidly develop transformative medicines for patients with unmet needs.At BridgeBio, we redefine boundaries, inspire creativity, and challenge conventional thinking. If you are a trailblazer ready to collaborate with esteemed industry professionals, we invite you to join us in redefining the future of biopharma. We champion curiosity and experimentation, including the ethical and thoughtful application of AI to enhance the clarity, speed, and quality of our work.Key ResponsibilitiesThe Associate Director/Director of Regulatory Advertising & Promotion will provide strategic regulatory oversight for promotional materials and external communications associated with designated programs or brands. This role is critical in ensuring that all promotional activities adhere to FDA regulations, industry standards, and company policies, while enabling the business to communicate effectively and maintain a competitive edge.

Join wordware.ai as a Staff Engineer where you will play a pivotal role in shaping the future of our innovative software solutions. We are looking for a talented engineer who thrives in a collaborative environment, is passionate about technology, and is eager to tackle complex challenges. Your expertise will help drive our product development and enhance the user experience for our clients.

Join Laurel as a Staff Data Engineer, where you will play a pivotal role in designing and implementing scalable data solutions. You will collaborate with cross-functional teams to optimize data architecture and enhance data analytics capabilities.

Join Parafin as a Staff Product Engineer and play a pivotal role in designing and building innovative products that make a difference. You will collaborate with cross-functional teams to deliver high-quality solutions that exceed customer expectations.

About Us:At Parafin, our mission is to empower small businesses by providing them with the financial support they need to thrive. Small businesses play a crucial role in our economy, yet they often face challenges in accessing traditional banking services. We develop innovative technology that simplifies access to essential financial tools through the platforms they already use for sales. By partnering with industry leaders like DoorDash, Amazon, Worldpay, and Mindbody, we deliver fast and adaptable funding solutions, spend management, and savings tools to small business users via seamless integrations. Parafin manages the complexities of capital markets, underwriting, servicing, compliance, and customer support on behalf of our partners.Our team of dedicated innovators comes from top-tier organizations such as Stripe, Square, Plaid, Coinbase, and Robinhood, all driven by a shared passion for creating solutions that foster the success of small businesses. Backed by prominent venture capital firms including GIC, Notable Capital, Redpoint Ventures, Ribbit Capital, and Thrive Capital, Parafin is a Series C company with over $194M raised in equity and $340M in debt facilities.Join us in shaping a future where every small business has the financial tools they deserve.About the Position:As a Staff Product Engineer at Parafin, you will be the go-to expert for our implemented products. You will collaborate across design, product, and backend teams to ensure that everything functions seamlessly. Our focus extends beyond specifications; we prioritize understanding the purpose of features, identifying users, and solving their problems. You will take ownership of the entire frontend experience, addressing every transition, edge case, and state change that occurs between user actions and screen outputs.While familiarity with our specific stack is not required, a strong foundation in JavaScript and experience shipping real products using React and TypeScript are essential.Your Responsibilities:Create Scalable, High-Quality User Experiences: Collaborate with design to deliver exceptional UI/UX while also managing critical aspects such as page performance, cross-browser compatibility, and mobile responsiveness.Gain In-Depth Product Knowledge: Develop a strong understanding and perspective on the products we build. Work closely with product and design teams to contribute to the development process, rather than merely executing specifications.Monitor and Enhance Performance: Implement observability for user interactions, core web vitals, and overall perceived performance.Build Frontend and Product Infrastructure: Participate in the development of build systems, developer tools, and deployment pipelines. Advocate for improvements in the developer experience and create internal tools to streamline processes.

Join Codegen as a Senior Staff Engineer, where your expertise will play a pivotal role in shaping our software solutions. We are looking for individuals with over a decade of robust software engineering experience, particularly in backend development, who are adept at independently designing and implementing large-scale, intricate systems. This is your chance to contribute to innovative projects in a role that offers both high autonomy and significant impact on our Python backend and associated technologies.About the RoleAs a full-time Senior Staff Engineer at Codegen, you will take ownership of critical segments of our Python backend, transforming them into reliable and scalable systems.In this role, you will iterate on features, prototype solutions, and refine them to meet enterprise standards. The ideal candidate will be self-motivated, capable of working independently while also collaborating effectively to drive projects to completion. This position is tailored for senior professionals who thrive in fast-paced environments and are passionate about cultivating an elite engineering culture.Our technology stack includes Python, OpenAPI APIs, FastAPI, and Modal for backend services, with strong integration with git, Retool for internal tools, and a minimal frontend built using Remix.js and TypeScript.