Regulatory Affairs Manager in United States

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. The Opportunity This Regulatory Affairs Manager – APAC position will work on-site at our Alameda, CA location in the Diabetes Care Division. We’re focused on helping people with diabetes manage their health with life-changing produc

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows. Job Description This is an office based/hybrid position. The Manager, Regulatory Affairs CMC is located in El Segundo, CA, Thousand Oaks, CA, Foster City, CA or Parsippany, NJ. Kite is transitioning from its current Santa Monica headquarters, with employees expected to relocate to our Thousand Oaks, CA, El Segundo, CA, Foster City CA or Parsippany, NJ office beginning in January 2027. While this role has the option to be based in Santa Monica through 2026, applicants should take this planned relocation into consideration. Kite supports a flexible working policy, offering a balanced approach with two days of remote working and three days working onsite. Support preparation and submission of CMC regulatory filings (INDs, CTAs, BLAs, MAAs, supplements, and variations), including submissions supporting lentiviral vector (LVV) manufacturing, testing, control strategy, and lifecycl

Work Flexibility: Onsite As the Manager, Quality Assurance , you will lead quality assurance activities that support product quality, process performance, audit readiness, and continuous improvement across site operations. Working closely with Operations, Global Quality, Regulatory Affairs, and supplier partners, you will help ensure quality systems remain effective, compliant, and aligned with business objectives. This role is Onsite in Mahwah, New Jersey . What You Will Do Lead the Quality Assurance team, providing technical guidance and quality oversight across manufacturing and operations, supports functions to drive continuous improvement and compliance. Partner with site leadership to ensure products consistently meet customer expectations, regulatory requirements, and applicable quality standards. Develop, coach, and retain a high-performing team while fostering a culture of inclusion, accountability, collaboration, and employee engagement. Drive quality system compliance by partnering with functional leaders to establish, communicate, and maintain quality standards, requirements, and responsibilities. Lead site readiness activities and support internal, corporate, notified body, FDA, and other regulatory audits and inspections. Oversee the management of nonconforming products, product and process deviations, risk assessments, corrective actions, and preventive actions to ensure effective resolution and compliance. Monitor and improve Quality performance indicators, including NCR, CAPA, compliance, and operational quality metrics, and implement corrective actions for adverse trends. Support the development and execution of local and global Quality Operations strategies that improve product quality, operational efficiency, risk management, and regulatory compliance. <

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows. Job Description Key Responsibilities Manage commercial pharmaceutical labeling projects from initiation through implementation. Coordinate labeling activities across Regulatory Affairs, Quality Assurance, Supply Chain, Manufacturing, Packaging Engineering, and external vendors. Lead artwork development, review, approval, and implementation activities. Manage project timelines, risks, priorities, and deliverables to ensure on-time execution. Review and approve artwork proofs, printer proofs, and packaging components for accuracy and compliance. Maintain labeli

About the Team OpenAI’s Legal team helps advance our mission by tackling novel legal issues in AI. Our team brings together professionals across technology, privacy, intellectual property, corporate, employment, tax, regulatory, and litigation. Our regulatory compliance work turns legal requirements into practical programs that support responsible AI development and deployment. About the Role As a Legal Program Manager focused on regulatory compliance, you will build and manage cross-functional programs that translate counsel’s guidance into practical, sustainable operations. Your initial focus may include content moderation and/or frontier AI governance, with the mix shaped by team priorities and your strengths. You will partner with internal and external counsel, other legal program managers, and technical and business teams to coordinate implementation, evidence collection, reporting, and ongoing compliance. You’ll build repeatable systems that scale across regulations, products, and jurisdictions, helping teams navigate emerging requirements with clarity and sound judgment. This full-time role is based in San Francisco, CA, or New York, NY. In this role, you will: Lead regulatory compliance programs end to end: define scope, owners, milestones, dependencies, risks, and escalation paths, and drive execution with counsel and cross-functional partners. Translate counsel’s regulatory guidance into repeatable workflows, controls, and documentation. Depending on your portfolio, this may include content moderation disclosures, transparency reporting, reporting and appeals workflows, or frontier AI model launch readiness, evaluation and risk-management evidence, and incident reporting. Build strong partnerships across Product, Engineering, User Operations, Governance, Risk and Compliance (GRC), Global Affairs, Communications, and Go-to-Market to align program priorities and deliverables. Support regulatory inquiries, audits and investigations with counsel, organizing ev

We’re building a world of health around every individual — shaping a more connected, convenient and compassionate health experience. At CVS Health®, you’ll be surrounded by passionate colleagues who care deeply, innovate with purpose, hold ourselves accountable and prioritize safety and quality in everything we do. Join us and be part of something bigger – helping to simplify health care one person, one family and one community at a time. Requisition Job Description Position Summary The Director, Corporate Affairs Technology leads the strategy, delivery, and operations of technology solutions supporting Legal, Compliance, and Corporate Security functions. This role partners with Corporate Affairs leadership to enable regulatory compliance, risk management, and enterprise protection through modern, scalable, and AI-driven technology solutions. This position is a leader-of-leaders role , with direct oversight of Senior Managers and their teams, and is accountable for delivering business-aligned outcomes across the Corporate Affairs application portfolio. Key Responsibilities Define and execute the technology strategy and multi-year roadmap for Corporate Affairs (Legal, Compliance, Corporate Security) Serve as a strategic partner to business leadership, aligning technology solutions to legal, compliance, and security priorities Lead and develop Senior Managers and their teams , ensuring strong performance, accountability, and organizational growth Own the end-to-end application portfolio , including design, delivery, operations, and modernization of platforms Champion AI, automation, and advanced analytics solutions to transform legal, compliance,

About the Team The Product Policy team develops and implements policies that shape how OpenAI’s technology is built and used. We work with teams across the company to turn complex questions about AI’s benefits and risks into practical guidance for responsible research, product development, and deployment. About the Role As Product Policy Manager, Regulation, you will map external regulatory and legislative trends and synthesize them into concrete research, product, and policy requirements. You will connect deep expertise in regulation and public policy with a sophisticated understanding of AI and strong product judgment. Your remit will span frontier AI, youth, wellbeing, use in high-stakes domains, deceptive use, and other emerging issues. Working closely with Legal and Global Affairs, you will help Product, Engineering, Research, and Safety teams understand what external developments mean for their work, what decisions or evidence are needed, and how to act. We’re looking for someone who combines deep regulatory and public-policy expertise with an in-depth understanding of AI and a demonstrated ability to advise product and engineering teams. You should be able to move from complex external developments to clear decisions and requirements that teams can implement. This role can be based in San Francisco or remote. We use a hybrid work model of 3 days in the office per week and offer relocation assistance to new employees. In this role, you will: Map and prioritize regulatory and legislative developments across jurisdictions and AI issue areas. Distinguish enacted requirements, proposals, guidance, and emerging expectations; assess their relevance, uncertainty, timing, and implications for our models and products. Translate external developments into actionable research questions, evaluation needs, product requirements, and policy recommendations. Identify gaps in evidence, define the intended outcome and acceptance criteria, and make tradeoffs and open questions c

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging cathe

Work Flexibility: Remote Staff Regulatory Affairs Specialist, Mako and Enabling Technologies (Remote) Join Stryker’s Ortho Tech Business and support a portfolio that spans robotics, navigation, imaging, software, and capital equipment technologies. In this role, you will provide regulatory leadership throughout the product lifecycle, partnering with cross-functional teams to support global product development, regulatory submissions, market access, and ongoing regulatory compliance across U.S. and international markets. Work Flexibility: This is a remote position, with a preference for candidates located in the U.S. Eastern Time Zone What You Will Do Develop and execute global regulatory strategies for new products, product changes, and lifecycle management activities. Participate in product development teams to ensure U.S., European, and international regulatory requirements are incorporated throughout all development phases. Evaluate product classifications, regulatory pathways, and jurisdictional requirements for medical devices and related technologies. Author and submit regulatory filings, including FDA submissions, international registrations, and supporting documentation required for product approvals. Review quality, preclinical, and clinical documentation to ensure submission readiness and regulatory compliance. Partner with global regulatory affiliates to support registrations, market expansions, and post-market regulatory activities. Lead interactions with regulatory authorities and notified bodies, including preparation of responses, submissions, and agency communications. Review product labeling, marketing materials, and product claims for compliance with applicable regulatory requirements and mentor junior regulatory team members on regulatory

Why join us Brex is the intelligent finance platform that enables companies to spend smarter and move faster in more than 200 markets. By combining global corporate cards and banking with intuitive spend management, bill pay, and travel software, Brex enables founders and finance teams to accelerate operations, gain real-time visibility, and control spend effortlessly. Brex’s AI-native automation and world-class service eliminate manual expense and accounting tasks for customers so they can focus on what matters most. Tens of thousands of the world's best companies run on Brex, including DoorDash, Coinbase, Robinhood, Zoom, Plaid, Reddit, and SeatGeek. Working at Brex allows you to push your limits, challenge the status quo, and collaborate with some of the brightest minds in the industry. We’re committed to building a diverse team and inclusive culture and believe your potential should only be limited by how big you can dream. We make this a reality by empowering you with the tools, resources, and support you need to grow your career. Legal at Brex The Legal team helps the company grow responsibly, advocating for Brex and for the thousands of growing businesses we serve. We provide strategic advice and guidance to all Brex teams, protect Brex, advise on risk, and represent the company externally, negotiating with partners and interacting with regulators. Reimagining the financial system in a highly regulated environment requires creativity and resourcefulness, and we welcome the challenge. Where you’ll work This role will be based in our San Francisco office. We are a hybrid environment that combines the energy and connections of being in the office with the benefits and flexibility of working from home. We currently require a minimum of three coordinated days in the office per week, Monday, Wednesday and Thursday. As a perk, we also have up to four weeks per year of fully remote work! What you'll do Reporting to the General Counsel, you will lead Brex's Regulatory

Why join us Brex is the intelligent finance platform that enables companies to spend smarter and move faster in more than 200 markets. By combining global corporate cards and banking with intuitive spend management, bill pay, and travel software, Brex enables founders and finance teams to accelerate operations, gain real-time visibility, and control spend effortlessly. Brex’s AI-native automation and world-class service eliminate manual expense and accounting tasks for customers so they can focus on what matters most. Tens of thousands of the world's best companies run on Brex, including DoorDash, Coinbase, Robinhood, Zoom, Plaid, Reddit, and SeatGeek. Working at Brex allows you to push your limits, challenge the status quo, and collaborate with some of the brightest minds in the industry. We’re committed to building a diverse team and inclusive culture and believe your potential should only be limited by how big you can dream. We make this a reality by empowering you with the tools, resources, and support you need to grow your career. Legal at Brex The Legal team helps the company grow responsibly, advocating for Brex and for the thousands of growing businesses we serve. We provide strategic advice and guidance to all Brex teams, protect Brex, advise on risk, and represent the company externally, negotiating with partners and interacting with regulators. Reimagining the financial system in a highly regulated environment requires creativity and resourcefulness, and we welcome the challenge. Where you’ll work This role will be based in our New York City office. We are a hybrid environment that combines the energy and connections of being in the office with the benefits and flexibility of working from home. We currently require a minimum of three coordinated days in the office per week, Monday, Wednesday and Thursday. As a perk, we also have up to four weeks per year of fully remote work! What you'll do Reporting to the General Counsel, you will lead Brex's Regulatory

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. RA Ad/Promo provides strategic regulatory guidance and input on Gilead's commercial and corporate communications, and plays a critical role ensuring that these activities are compliant with governing laws, regulations, and Gilead policies and procedures, while enabling the business to compliantly meet its goals and objectives. This group also represents Gilead's commercial activities to U.S. regulatory agencies. You will manage the commercial regulatory strategy and execution of such for multip

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. Your Role at Baxter Baxter is seeking an experienced leader to oversee Product Stewardship and the execution of environmental and social product-related regulatory programs across the enterprise. This role is responsible for monitoring emerging regulations, assessing business applicability, establishing implementation roadmaps, and driving cross-functional execution to ensure compliance across Baxter's global portfolio. The leader will work closely with business segments, drive collaboration with other functions such as R&D, Regulatory Affairs, Quality, and Legal, and Operations teams to translate evolving requirements into practical and timely actions. Success in this role requires exceptional program management, organizational leadership, and execution capabilities. The individual must be skilled at coordinating complex initiatives across multiple stakeholders, driving accountability, and ensuring that Baxter remains ahead of regulatory requirements while proactively identifying opportunities to develop products and solutions that

About Us OpenFX is on a mission to move money as freely as data, unrestricted by time zones, banking hours, or legacy systems. We are building the infrastructure that will power the next generation of cross-border payment systems for institutions. The team's execution has been exceptional, and we're scaling at a remarkable pace. Our stellar early team comes with experience in companies like J.P. Morgan, Goldman Sachs, FalconX, Paypal, Affirm, Polygon, Kraken, Nium & others. We’re backed by Accel, Lightspeed, NfX and other top-tier investors. Role Overview We're seeking an exceptional Americas Legal Counsel to serve as a strategic partner and legal advisor across our business, with a particular focus on financial products and partnerships. This role combines the intellectual challenge of navigating cutting-edge financial technology with the opportunity to shape legal strategy in the early stages at a high-growth company. You'll work on some of the most complex and interesting problems at the intersection of cross-border payments, cryptocurrency, foreign exchange and technology—providing pragmatic, business-oriented counsel that enables rapid growth while managing risk effectively. The ideal candidate is a team player who is energized by a high-growth environment and translating complex legal requirements and legal ambiguity into clear, actionable strategies. You move quickly with sound judgment, and excel as a trusted senior advisor to product, engineering, compliance, and business teams. Key Responsibilities: Product Legal Advise product and engineering teams on the legal and regulatory aspects of product design, development, and launch, with a particular focus on payment and banking products Translate complex regulatory requirements into clear guidance that helps teams build compliant products while growing rapidly Regulatory & Licensing Strategy Partner closely with business teams and compliance to develop and execute licensing and market entry strategies

We anticipate the application window for this opening will close on - 17 Oct 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72&#43; million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life Cranial and Spinal Technologies develops products and therapies for neurosurgical and spinal procedures, supporting physicians with technologies that improve patient outcomes. This technical writing function is responsible for developing and maintaining Instructions for Use (IFU) and related product documentation for regulated medical devices throughout the product lifecycle. The role partners closely with Product Development, Marketing, Regulatory Affairs, and other cross-functional teams to ensure documentation is accurate, compliant, and available to global users. Check us out on LinkedIn: Medtronic CST This position is based onsite in Lafayette, Colorado. Limited domestic and international travel may be required, with an expected travel commitment of less than 10%. In this role, you will develop, maintain, and manage product documentation for medical device products, including Instructions for Use (IFU), system manuals, quick reference guides, technical bulletins, and o