Staff Regulatory Affairs Engineer

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.

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.

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.

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.

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.

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 Mercury as a Senior Counsel specializing in Product & Regulatory aspects for Investment Products. In this pivotal role, you will lead legal guidance on product development and regulatory compliance, ensuring our offerings meet the highest standards of integrity and innovation. Collaborate with cross-functional teams to address complex legal issues and drive strategic initiatives that align with our mission to empower businesses in the financial technology sector.

Join Us at BrexBrex is revolutionizing the way businesses manage their finances with our AI-powered spend platform. We provide integrated corporate cards, banking solutions, and global payment options, alongside user-friendly software for travel and expense management. Our platform is trusted by tens of thousands of companies, ranging from innovative startups to established enterprises like DoorDash, Flexport, and Compass, empowering them to manage spending responsibly, reduce costs, and enhance operational efficiency.At Brex, we encourage you to challenge yourself, innovate, and collaborate with some of the brightest professionals in the field. We are dedicated to fostering a diverse team and an inclusive work culture where your ambitions can grow unhindered. We equip you with the necessary tools, resources, and support to advance your career.About the Legal Team at BrexThe Legal team is integral to our mission, ensuring that we grow responsibly while advocating for both Brex and our extensive client base. We provide strategic guidance to all departments, manage legal risks, and represent the company in negotiations and regulatory discussions. Navigating the complexities of the financial landscape in a highly regulated environment demands creativity and resourcefulness, and we embrace this challenge.Your RoleAs a Product and Regulatory Counsel, you will play a vital role in enhancing our global commercial card products, banking services, and related financial offerings. You will be the go-to expert on card and financial regulations, providing strategic insights on risk management and navigating regulatory uncertainties. Collaborating closely with stakeholders across product, engineering, marketing, sales, and partnerships, you will devise innovative solutions for business challenges.

Join Airwallex as Our Senior Regulatory Counsel, AmericasAt Airwallex, we are revolutionizing the way global businesses manage their finances. As the only unified payments and financial platform catered specifically for international enterprises, we proudly serve over 200,000 clients, including renowned companies like Brex, Rippling, Navan, Qantas, and SHEIN. Our innovative solutions encompass everything from business accounts to treasury management and embedded finance, enabling seamless operations on a global scale.Founded in Melbourne, our talented team of over 2,000 professionals spans 26 offices worldwide. With a valuation of USD 8 billion and support from leading investors such as T. Rowe Price, Visa, Mastercard, and Sequoia, we are at the forefront of shaping the future of global payments and finance. If you are ready to take on a challenge that will define your career, we invite you to join our mission.What We ValueWe are looking for creators and innovators with the spirit of entrepreneurs who seek to make a substantial impact. You should possess deep expertise in your field, be driven by our mission, and align with our operating principles. Your quick decision-making, curiosity, and ability to balance speed with analytical rigor are crucial.You are a collaborative and humble team player who transforms ideas into tangible products, successfully delivering results from inception to completion. Embrace AI to enhance your productivity and efficiency. Here, you'll engage with complex challenges alongside exceptional colleagues, advancing your career as we reshape the landscape of global banking.About Our TeamThe Legal, Risk & Compliance (LRC) team is an integral part of Airwallex, comprising skilled legal professionals and risk management specialists. Our mission is to protect the integrity of Airwallex's operations while fostering a culture of compliance and ethical practices. We are committed to guiding the organization through the complexities of the global financial environment by proactively identifying and managing legal and compliance risks.Your RoleIn this pivotal role, you will lead regulatory initiatives across the Americas, focusing on complex issues in payments and financial services, including licensing, money transmission, and compliance.

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.

Nium: A Global Leader in Payments Nium is at the forefront of real-time, cross-border payments, committed to shaping the future of global payments infrastructure. Our mission is to empower banks, fintechs, and businesses to instantly manage their funds across borders, fostering a seamless global economy.With a payout network supporting over 100 currencies across 220+ markets, including real-time capabilities in 100 of them, we facilitate local fund collection in 35 markets and our card issuance services are expanding rapidly, currently available in 34 countries. Holding regulatory licenses in more than 40 countries, we ensure swift onboarding and compliance regardless of geographical barriers. Nium operates from its co-headquarters in San Francisco and Singapore.About Our Team The Global Legal Team at Nium works at the critical intersection of fintech innovation and regulatory compliance. Our efforts are vital in guiding Nium to build cutting-edge products while effectively managing risks and navigating complex regulatory landscapes.Position Overview We are seeking an enthusiastic and adaptable Senior Product & Regulatory Counsel to join our San Francisco office, aimed at supporting our rapid expansion across North and South America. In this pivotal role, you will serve as a strategic advisor to diverse teams, including Product, Engineering, Compliance, Bank Partnerships, and Marketing. You will be instrumental in designing innovative payment products and services, providing key insights on Nium's legal and regulatory obligations in the Americas, and driving our market expansion efforts.Your expertise should encompass US money transmission licensing (MTLs), cross-border payment regulations, US bank sponsorship, and financial services law, enabling us to propel our licensing and growth initiatives in the region. Familiarity with regulatory frameworks in Canada, Brazil, and Mexico is essential, or a willingness to quickly learn these complexities.

At Olema Oncology, we are committed to pioneering innovative treatments for breast cancer and beyond. Our flagship program, palazestrant (OP-1250), is a revolutionary complete estrogen receptor antagonist (CERAN) currently under development for metastatic breast cancer, showcasing significant potential as both a standalone treatment and in combination therapies for ER+/HER2- metastatic breast cancer. Additionally, our next product candidate, OP-3136, is a potent KAT6 inhibitor with the potential to be best-in-class.Our scientific achievements are driven by a culture of fearless support, motivation, and challenge amongst our team members. At Olema, we believe that prioritizing our people translates into unparalleled work. If you are eager to be part of an unstoppable force and make a substantial impact on patients' lives, your career, and the future, let’s unite in this mission.Explore our latest corporate presentations here.Position Overview: Associate Director, Regulatory Affairs CMCIn the role of Associate Director of Regulatory Affairs CMC, you will report to the Senior Director of Regulatory Affairs CMC. Your main responsibilities will include developing and executing comprehensive CMC regulatory strategies for Olema’s products throughout their development and post-approval phases. You will ensure these strategies are in compliance with global Health Authority requirements and provide guidance and oversight for producing high-quality, timely CMC sections of regulatory submissions. Furthermore, you will offer CMC regulatory strategy support to cross-functional teams within the organization.This position is based in our San Francisco, CA office and will require approximately 10% travel.Your Responsibilities Will Include:Providing CMC regulatory expertise for global development and registration programs (e.g., INDs, CTAs, BLAs, and MAAs).Supporting regulatory agency interactions to ensure alignment on CMC strategies for initial INDs/CTAs, marketing registration applications, supplements, and variations.Offering CMC support for the global regulatory plan, development plans, clinical study designs, and risk assessments.Proactively communicating critical issues and potential mitigations to teams, senior management, and key stakeholders in a timely manner.Assessing and conveying regulatory requirements to ensure compliance with applicable regulations and guidelines throughout development activities.Managing and ensuring compliance with all reporting requirements.

Join a dynamic and rapidly expanding startup in stealth mode as a Senior Product and Regulatory Counsel. This role is more than just a legal position; it is a fundamental part of our client's mission to innovate and impact the world positively. You will collaborate closely with legal, engineering, and program teams to navigate legal complexities in technology development, investments, and private foundations across highly regulated industries both domestically and internationally. Our client is driven by the belief that advanced software and hardware can enhance global safety and freedom. With a leadership team of esteemed technologists, this company is on an exponential growth trajectory, committed to redefining what's achievable through technology. We are seeking a talented Senior Legal Counsel to contribute to this innovative vision. Your primary mission will be to offer proactive legal, operational, and regulatory support that accelerates product development, strengthens data and information security, and safeguards intellectual property—all aimed at expanding the limits of innovation and enhancing the global environment.

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.

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.

Grindr is an AI-driven platform connecting millions of gay people worldwide. With over 15 million users monthly and more than 130 billion messages exchanged each year, the team addresses technical and regulatory challenges at a significant scale. Fewer than 200 employees keep operations agile and thoughtful. Role overview The Health Regulatory Counsel will help shape Grindr's expanding health business. This position provides guidance on health regulatory issues, compliance, product development, and privacy matters. Acting as a key advisor, the counsel works closely with leadership and cross-functional teams to support high-impact decisions. Work culture Grindr emphasizes a balanced approach: maintaining high standards while respecting personal well-being. The company values outcomes, encourages smart collaboration, and supports a full life outside the office. Location and schedule This hybrid role requires in-person attendance on Tuesdays and Thursdays at one of these offices: San Francisco New York City Los Angeles

Join a pioneering, mission-driven fintech company that leverages AI to empower businesses with integrated corporate cards, banking solutions, and spend management software. Solutus Legal Search has been exclusively retained to find a talented Product and Regulatory Counsel who will play a crucial role in the global growth and enhancement of the company's commercial card product, banking offerings, and associated payment solutions. As a key member reporting to the Associate General Counsel of Product & Regulatory, you will become the go-to expert on financial regulations and card compliance, offering strategic guidance on risk management and regulatory challenges. You will collaborate closely with cross-functional teams, including product development, engineering, marketing, sales, and partnerships, to devise innovative solutions for business challenges. Your ability to deconstruct projects into essential principles will be vital as you guide initiatives from conception to launch, discerning when to utilize in-house resources versus when to engage external counsel effectively. The ideal candidate will possess over four years of experience in law firms and fintech environments, adept at engaging with commercial banking partners, financial regulators, and card networks. A solid understanding of federal, state, and international regulations affecting fintech, including UDAP, anti-money laundering statutes, the CARD Act, ACH guidelines, and money transmission laws, is essential. Experience with stablecoins and broker-dealer legal issues is highly desirable. We seek a candidate who exhibits an entrepreneurial spirit and ownership mentality, with the ability to navigate complex matters requiring sound judgment. A collaborative team player, you will be eager to assist colleagues and thrive in a fast-paced environment.

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.