Regulatory Operations Analyst in United States

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

We believe that the way people interact with their finances will drastically improve in the next few years. We’re dedicated to empowering this transformation by building the tools and experiences that thousands of developers use to create their own products. Plaid powers the tools millions of people rely on to live a healthier financial life. We work with thousands of companies like Venmo, SoFi, several of the Fortune 500, and many of the largest banks to make it easy for people to connect their financial accounts to the apps and services they want to use. Plaid’s network covers 12,000 financial institutions across the US, Canada, UK and Europe. Founded in 2013, the company is headquartered in San Francisco with offices in New York, Seattle, Washington D.C., Raleigh, London, and Amsterdam. About the team The Privacy & Regulatory Counsel will join Plaid’s Privacy & Regulatory Legal team, which supports Plaid in building infrastructure and products responsibly by translating complex regulatory expectations into concrete guidance. We are a lean, highly collaborative team that includes Privacy and Regulatory counseling. Role Description As Privacy & Regulatory Counsel at Plaid, you will partner with cross-functional teams to analyze complex legal and regulatory issues, provide practical guidance, and support business initiatives in compliance with applicable laws and regulations. This role is ideal for an ambitious attorney who exhibits a growth mindset and eagerness to learn. We value strong communicators who can empathize with business partners, deliver solutions-oriented advice, and foster trust with colleagues at all levels. Responsibilities Monitor and analyze new or changing laws, regulations, supervisory guidance, enforcement activity, and industry developments - and translate them into concise and practical guidance. Answer questions about regulatory compliance for Product, Governance, People, and other cross functional teams. Maintain Plaid’s regula

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 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 catheters and s

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

About the Team OpenAI's Legal team plays a crucial role in furthering OpenAI's mission by tackling innovative, fundamental legal issues in AI. If you're passionate about doing significant and unique work as a technology lawyer, this team is for you. The team comprises legal professionals from diverse fields, including technology, privacy, IP, corporate, cybersecurity, employment, tax, regulatory, and litigation. About the Role We’re growing our Litigation and Regulatory team and seek an experienced counsel to lead high-stakes regulatory investigations, enforcement matters, and related litigation involving AI. You will own matters from initial inquiry through resolution, develop practical strategies for novel and technically complex issues, and translate an evolving factual record into clear advice. The role works closely with Legal, Product, Research, Safety, Security, Communications, Global Affairs, and executive stakeholders. This role is based in San Francisco, CA. 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: Lead regulatory inquiries, investigations, and enforcement matters in the United States and internationally, including matters involving federal agencies, state attorneys general, and international regulatory bodies. Develop strategy for contested enforcement proceedings and related litigation, including challenges to investigative demands and coordination across parallel matters. Partner with litigation and subject-matter counsel on related civil disputes, including privacy, consumer protection, class actions, cybersecurity, competition, copyright, trademark, and other IP issues. Manage subpoenas, civil investigative demands, requests for information from regulators and related entities, and discovery. Prepare employees and executives for interviews, testimony, depositions, trial, and other appearances before regulators. Negotiate resolutions to demands, complaints, and

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

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

Job Title Senior Supplier Quality Engineer Job Description The Senior Supplier Quality Engineer ensures supplier quality, compliance, and process capability across sustaining activities within Philips’ Image Guided Therapy Devices business. Your role: Serves as the primary Supplier Quality Engineering point of contact for the Colorado Springs, CO facility, providing on-site support ensuring timely alignment with site Quality, Manufacturing, R&D, Sustaining Engineering, Procurement, and supplier stakeholders. Leads and owns MSA, PFMEA, Control Plan, SPC, PV&V, FAI, IQ/OQ/PQ, and related APQP / PPAP activities to ensure supplier process capability, validation readiness, and compliance with quality requirements. Leads APQP / PPAP execution for supplier transfers, supplier changes, SICRs, and sustaining projects supporting the Fremont, CA manufacturing facility. Facilitates Design for Excellence collaboration between R&D, Sustaining Engineering, Manufacturing, and suppliers to improve design quality, manufacturability, supplier process robustness, and long-term product performance. Ensures Critical to Quality characteristics are clearly defined, flowed down to suppliers, validated through appropriate controls, and maintained throughout production. Leads supplier audits, including initial qualification, for-cause, and follow-up audits, to assess supplier compliance with applicable quality system requirements, regulatory expectations, process controls, and supplier agreement obligations. Leads supplier qualification activities for addition to the Approved Supplier List, including supplier capability assessment, quality system maturity evaluation, technical readiness, risk classification, approval documentation, and onboarding completion. Leads supplier-related non-conformance investigations, including defect

Worldwide Technical Regulation Compliance Engineer Description - At HP, we create technology that makes life better for everyone, everywhere. As a Worldwide Technical Regulations (WTR) Compliance Engineer, you will play a critical role in ensuring HP products meet global regulatory, safety, environmental, cybersecurity, telecommunications, and market access requirements. Working as part of the WTR , you will collaborate with product development teams, manufacturing partners, certification laboratories, and regulatory experts worldwide to enable compliant and successful product launches. You will help drive compliance strategies throughout the product development lifecycle while balancing technical, business, and schedule objectives. This role provides the opportunity to influence products sold globally and work with experts across engineering, cybersecurity, sustainability, and regulatory compliance disciplines. Success in this Role Successful candidates are curious, collaborative, and technically strong engineers who enjoy solving complex compliance challenges. They are capable of balancing detailed technical requirements with business priorities and can influence diverse stakeholders to achieve compliant, on-time product launches. Responsibilities: Ensure HP products comply with applicable global regulatory and technical requirements, including Safety, EMC, Wireless/Telecom, Energy Efficiency and Cybersecurity regulations. Partner with product development teams early in the design cycle to identify regulatory requirements and compliance risks. Manage compliance activities for multiple product development programs from concept through commercialization. Develop and execute certification strategies that support product launch schedules and worldwide market access o

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. This job is eligible for same day offers as part of our Direct Hire program. Hours: M- F 5:00am-1:00pm with Mandatory Overtime We are seeking a detail-oriented Pharmacy Order Selector to join our distribution team. This role is responsible for accurately selecting and preparing pharmacy orders for shipment, ensuring compliance with safety and regulatory standards. If you enjoy working in a fast-paced environment and value accuracy and quality, this is a great opportunity for you! Responsibilities Accurately pick and pack pharmacy orders based on system-generated lists. Verify product information, lot numbers, and expiration dates to ensure compliance. Prepare orders for shipment by labeling and securing packages. Maintain a clean and organized work area following all safety and regulatory guidelines. Assist with inventory control and cycle counts as needed. Participate in training for additional warehouse and compliance duties. Qualifications Strong attention to detail and organizational skills. Ability to lift up to 50 lbs and stand for extended periods. Ability to work independently and as part of a team. Previous experience in pharmacy or distribution preferred (0–2 years). Education High school diploma or equivalent required.

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. We are seeking a dependable Pharmacy Stock Handler to join our pharmacy distribution team. This role is responsible for accurately stocking and organizing pharmacy products, ensuring compliance with safety and regulatory standards. If you enjoy working in a fast-paced environment and value accuracy and organization, this is a great opportunity for you! Responsibilities Stock and organize pharmacy products in designated areas. Verify product information, lot numbers, and expiration dates. Maintain accurate inventory records using warehouse management systems (WMS). Ensure compliance with all safety and regulatory guidelines. Assist with general warehouse duties as needed. Qualifications Strong attention to detail and organizational skills. Ability to lift up to 50 lbs and stand for extended periods. Basic computer skills and experience with inventory systems preferred. Previous experience in pharmacy or distribution preferred (0–2 years). Education High school diploma or equivalent required. Benefits Competitive pay. Health, dental, and vision insurance options. Holiday differential. Employee discount program. Opportunities for growth and advancement. <p style="te

Work Flexibility: Field-based Emergency Care (Fire/EMS) Sales Representative As a Sales Representative at Stryker, you will be at the forefront of promoting and selling our Emergency Care products, with a focus on Fire Emergency Medical Services solutions, to pre-hospital providers. You’ll work with a diverse range of products, including Emergency Patient Transport, Defibrillators, Automated External Defibrillators (AED), and Chest Compression systems. This role will involve building and maintaining strong customer relationships, addressing inquiries, negotiating pricing, and managing orders seamlessly. By staying informed on industry trends, competitor activity, and regulatory shifts, you’ll position Stryker’s products effectively in the marketplace. You’ll also have the opportunity to exceed sales targets, monitor your performance, and collaborate with marketing and support teams to drive business growth and success. What you will do Continue experience in sales or clinical setting. Promote and sell Stryker Emergency Care products to meet our customers’ needs. Achieve your assigned quota by taking a consultative approach to Pre-Hospital sales, marketing, clinical and demonstrations of all related Fire/Emergency Medical Services products and programs. Become the resident Emergency Care expert as you work with a sophisticated audience of fire chiefs, medical directors, clinical instructors and administrators. Your knowledge not only of your own products, but of competitors’ offerings, builds credibility with your customers. <span style="f

Strength in Trust OneTrust’s mission is to enable innovation through the responsible use of data and AI. We believe that ensuring data is trusted shouldn’t slow teams down—it should accelerate what’s possible. This led us to develop the first technology platform for responsible data use in 2016. Today, with AI representing the latest and most impactful expansion of data yet, OneTrust is once again redefining what responsible innovation looks like. OneTrust, the AI‑Ready Governance Platform™, unifies regulatory intelligence, automation, and connected governance workflows so businesses can continue to move at the speed of AI while ensuring good governance to prevent data misuse at scale. Trusted by thousands of organizations worldwide, OneTrust is shaping the future where trusted data becomes a transformative force for business and society. The Challenge We're looking for a Solutions Engineer (SE) to join our Solutions Engineering team. In this role, you'll partner closely with Sales to help prospective customers understand how OneTrust can address complex privacy, security, governance, and compliance challenges. As a trusted technical advisor, you'll guide customers through discovery, product demonstrations, technical evaluations, proof-of-concepts, and integration discussions. You'll help organizations evaluate how OneTrust solutions fit within their existing technology ecosystem while collaborating with Product, Engineering, and Customer Success teams to drive successful outcomes throughout the sales process. Your Mission Serve as a technical resource throughout the sales cycle, partnering with Account Executives to support new business opportunities. Deliver compelling product demonstrations and technical presentations tailored to customer requirements and business objectives. Conduct technical discovery sessions to understand customer environments, workflows, and integration needs. Support proof-of-concept evaluations and demonstrate how OneTrust sol

Strength in Trust OneTrust’s mission is to enable innovation through the responsible use of data and AI. We believe that ensuring data is trusted shouldn’t slow teams down—it should accelerate what’s possible. This led us to develop the first technology platform for responsible data use in 2016. Today, with AI representing the latest and most impactful expansion of data yet, OneTrust is once again redefining what responsible innovation looks like. OneTrust, the AI‑Ready Governance Platform™, unifies regulatory intelligence, automation, and connected governance workflows so businesses can continue to move at the speed of AI while ensuring good governance to prevent data misuse at scale. Trusted by thousands of organizations worldwide, OneTrust is shaping the future where trusted data becomes a transformative force for business and society. The Challenge As a Senior Staff Software Engineer, you will serve as a technical leader for OneTrust’s AI Governance (AIG) platform, driving the design, scalability, and reliability of systems that enable enterprises to deploy and govern AI and LLM-powered applications responsibly. You will deeply understand how customers build, deploy, and operate AI systems, and translate those needs into secure, compliant, and observable platform capabilities. Your Mission Development Lead the design and development of Java/Python microservices and shared libraries integrating with AI platforms for OneTrust’s AI Governance product. Design, build, and test cloud-native applications deployed on Microsoft Azure using Core Java, REST, and the Spring ecosystem. Lead the architecture and development of reusable AIG reporting and dashboard capabilities that integrate governance data from SQL databases and analytical platforms with runtime observability signals. Design reusable semantic-layer and metric-abstraction capabilities, including dataset contracts, metric defini

Strength in Trust OneTrust’s mission is to enable innovation through the responsible use of data and AI. We believe that ensuring data is trusted shouldn’t slow teams down—it should accelerate what’s possible. This led us to develop the first technology platform for responsible data use in 2016. Today, with AI representing the latest and most impactful expansion of data yet, OneTrust is once again redefining what responsible innovation looks like. OneTrust, the AI‑Ready Governance Platform™, unifies regulatory intelligence, automation, and connected governance workflows so businesses can continue to move at the speed of AI while ensuring good governance to prevent data misuse at scale. Trusted by thousands of organizations worldwide, OneTrust is shaping the future where trusted data becomes a transformative force for business and society. The Challenge As a Senior Staff Software Engineer, you will serve as a technical leader for OneTrust’s AI Governance (AIG) platform, driving the design, scalability, and reliability of systems that enable enterprises to deploy and govern AI and LLM-powered applications responsibly. You will deeply understand how customers build, deploy, and operate AI systems, and translate those needs into secure, compliant, and observable platform capabilities. Your Mission Development Lead the design and development of Java/Python microservices and shared libraries integrating with AI platforms for OneTrust’s AI Governance product. Design, build, and test cloud-native applications deployed on Microsoft Azure using Core Java, REST, and the Spring ecosystem. Lead the architecture and development of reusable AIG reporting and dashboard capabilities that integrate governance data from SQL databases and analytical platforms with runtime observability signals. Design reusable semantic-layer and metric-abstraction capabilities, including dataset contracts, metric defini