Regulatory Affairs Cmc Associate Jobs

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

Atlas HXM is the global workforce platform built on compliance. We help companies determine how to engage each member of their workforce and then execute with accountability built in — direct Employer of Record (EOR), Agent of Record (AOR), payroll, and compliance capabilities backed by a decade of practitioner-led expertise. Recognized as a category Leader by NelsonHall and Everest Group, Atlas HXM builds Human Experience Management into everything we do, guided by our "For People, by People" principle. The future of work is borderless, and so are we. Our people are located around the globe — in the U.S., the UK, India, Colombia, China, and beyond. Diversity and belonging are not just values; they are who we are. We are also committed to making a positive impact. Through our Environment, Social, and Governance (ESG) impact initiative, we are addressing our environmental footprint and promoting social responsibility. Our impact program is central to our vision and culture, focusing on employee wellness, diversity, charitable work, and ethical corporate governance. The Senior Regulatory Affairs & Entity Corporate Governance Manager will lead the company’s regulatory strategy, ensuring compliance with all relevant regulations. This senior role focuses on managing regulatory affairs for the organization and providing strategic guidance on governance matters to support our corporate entities globally. The Senior Regulatory Affairs & Entity Corporate Governance Manager will work closely with legal, risk & compliance, and operational teams to implement a regulatory framework that meets both local and international requirements while fostering best practices in corporate governance. This is a 10-month fixed-term contract for an individual contributor. Key Responsibilities Regulatory Strategy Develop and execute a comprehensive regulatory strategy that aligns with the company's business objectives and supports its global operations. Monitor and interp

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

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+ 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 JOB TITLE: シニア薬事スペシャリスト DEPARTMENT: 品質保証・薬事（薬事Cardiovascular/DIBポートフォリオ） REPORTING TO: 薬事マネジャー ********************************************************************************************** Main Mission of Job “Being a “bridge” to deliver “meaningful” medical device to Japanese patients” 日本の患者さんに価値のある医療機器を届ける架け橋となる Main Responsibilities 血管内治療機器に関連する薬事業務に従事いただきます。 新製品のタイムリーな国内導入に向け、その製品特性、開発計画、市場およびビジネス上のニーズ、上市戦略を理解し、米国本社およびマーケティング部門と協力して、薬事承認および保険に関する申請戦略および作業計画を立案する。 薬事申請戦略および作業計画に基づき、米国本社および国内関連部門の協力を得て必要な情報を収集し、行政当局との相談を行いながら、質の高い申請書を効率よく作成して審査当局に提出し、承認取得する。 保険申請戦略に基づき、必要な申請書を作成し当局に提出する。区分C1またはC2申請を行う場合は、マーケティング部門、保険担当部門と協力して、国内外のエビデンスの収集、保険適用申請書の作成と提出、説明資料の作成、関連学会や行政当局との折衝を行う。 製品の流通に際し、モデル情報の登録や帳票類の整備等、付帯する薬事関連業務を行う。 米国本社との良好な信頼関係とコミュニケーションを維持して、必要な情報をタイムリーかつ正確に取得し、薬事行政上の必要な判断や措置を遅滞なく講じる。 国内薬事関連法令やグローバルな薬事行政の動向、担当する製品群および関連治療についての最新の情報・知識を収集する。 業界活動を通じ、品目の基準作成、薬事関連、保険関連などにおいて、業界側の考えを行政に提案する。 Must Haves 学士（４年制理系大学卒）以上又はそれに相当する学位 医療機器又は医薬品の薬事申請業務（クラスⅣの医療機器の薬事申請経験があれば尚可） 米国本社との情報交換及び技術英語読解に必要な英語能力

Deputy General Manager - Regulatory for AGEL Source: Adani Group | Job ID: 57052

Principal Regulatory Affairs Specialist, (Hybrid) — Portage, Michigan. Apply via Workday.

Senior Regulatory Affairs Specialist - Onsite — Irvine, California, United States of America. Apply via Workday.

Senior Regulatory Affairs Specialist - Lingo (on-site) — United States - California - Alameda. Apply via Workday.

Associate Regulatory Affairs Specialist — Bogota, Colombia. Apply via Workday.

Staff Regulatory Affairs Specialist (Remote) — Fremont, California. Apply via Workday.

Senior Regulatory Affairs Manager — 5 Locations. Apply via Workday.

JOB DESCRIPTION: Job Description Core Job Responsibilities: With Manager Oversight and Supervision: Global Labeling Portfolio: Develops and maintains EPD Company Core Data Sheets (CCDS) and Company Core Patient Information (Master Package Leaflet) based on the available scientific knowledge, labeling guidelines and requirements within the Abbott EPD Labeling Process. Ensures CCDS information is based on Subject Matter Expert (SME) contribution. Organizes and participates in Labeling Sub-Team (LST) meetings, ensuring appropriate actions are followed through. Working with Product Leads, SMEs and cross functional teams ensures appropriate documentation to support label changes (clinical overviews, Module 5 documents, Literature References, etc.) are available to complete labeling project. With oversight, independently completes labeling activities assigned. Assesses and approves change requests for labeling documents. Able to participate and contribute to labeling decisions within cross-functional teams. Supervises lab

Shape the Future with Dun & Bradstreet At Dun & Bradstreet, we believe data has the power to create a better tomorrow. As a global leader in business decisioning data and analytics, we help companies worldwide grow, manage risk, and innovate. Since 1841, businesses have trusted us to turn uncertainty into opportunity. We’re a diverse, global team that values creativity, collaboration, and bold ideas. Are you ready to make an impact and help shape what’s next? Join us! Explore opportunities at dnb.com/careers. We are so excited to now be looking for an experienced public policy and regulatory affairs professional to help us anticipate and navigate a rapidly evolving global regulatory landscape. Reporting to our Senior Director, Public Policy & Regulatory Affairs in London, you'll play a key role in shaping our approach to regulatory change across Europe and globally. You'll lead important elements of our global regulatory readiness programme while supporting the development of policy positions, advocacy strategies and engagement with policymakers, regulators and industry bodies. You'll work closely with senior leaders and teams across the business to assess emerging regulatory developments, understand their potential impact and translate complex requirements into clear, practical recommendations. Your remit will span some of the most important issues affecting the data and technology sector, including AI, data protection, financial crime, consumer protection, ESG, competition and international trade. This is an opportunity to combine regulatory insight, public policy and business strategy in a highly visible global role, helping Dun & Bradstreet respond effectively to regulatory change while supporting responsible innovation and growth. Based in our beautiful offices in Paddington, London, this role works on a hybrid basis with at least 3 days on site and will require occasional travel. What You'll Do: Regulatory Strategy & Readiness Monito

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

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