Senior Regulatory Affairs Specialist Jobs

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

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

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

Senior Specialist Regulatory Affairs — Irvine, California. Apply via Workday.

Job Description Job Title: Senior Executive / Specialist - Case Processing E mployment Type: Contract Location: Brazil (Remote) A bout ClinChoice ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis. Our global delivery network has expanded to centers and satellite offices in the United States, Mexico, United Kingdom, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally. We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision. Primary Responsibilities: Experience in Intake/Triage, Data Entry, Quality Review, Case Finalization/Distribution of cases received from sources such as Spontaneous, Literature, Regulatory Authority, Solicited and Clinical trials. Experience in raising follow-up queries, as necessary, with appropriate documentation in the safety database. Experience in ARGUS database. Experience in rare disease portfolio. Must possess thorough knowledge of ICH-GCP, relevant GVP module, 21 CFR guidelines and other regulatory requirements. Training and mentoring skill (ICSR, Safety database etc.). Candidate Profile: Bachelor’s or Master’s in Pharmacy / Life Sciences or above and in alignment with project / business team requirements. Minimum of 3 to 5 years of relevant experience in identified functional domain/ business workstream. Must have hands on experience with MS office applications (Outlook, Excel, Word, Power Point

About the team OpenAI’s mission is to ensure that artificial general intelligence benefits all of humanity. OpenAI for Government (OAI4G) helps public-sector institutions understand, adopt, and deploy highly capable AI products in support of their missions. The team brings together Sales, Solutions, Partnerships, Technical Success, Legal, Security, Policy, Global Affairs, and other cross-functional partners to help governments use AI responsibly and effectively. As part of OAI4G’s International Public Sector team, you will help public institutions in Australia and New Zealand (ANZ) and APAC translate frontier AI into secure, compliant, mission-aligned outcomes. We work across varied procurement, regulatory, security, sovereignty, and commercial environments, while maintaining a consistent commitment to safety, reliability, and public benefit. About the role We are seeking a senior Account Director (AD) to lead OpenAI’s public-sector work across ANZ, with a wider remit to develop selected priority opportunities across APAC. ANZ will be the centre of gravity for the role: you will build trusted relationships with government leaders, develop and execute account strategies, create and close complex opportunities, and help customers move from initial interest to successful adoption. This is a full-cycle, highly cross-functional sales role that combines technical understanding, strategic vision, partnership management, and value-driven execution. You will work with senior government, operational, technical, procurement, policy, and security stakeholders to identify high-impact AI use cases and translate them into credible commercial and deployment pathways across the OpenAI Platform API and Codex and ChatGPT Enterprise. You will also be an accountable customer leader after signature, working alongside specialist delivery and technical teams to keep customer outcomes, milestones, adoption, risks, and executive alignment on track. The role requires excellent judgement, exec

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

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. Head of Global Regulatory Affairs and Entity Corporate Governance (12-month fixed-term maternity cover) The Head of Global Regulatory Affairs and Entity Corporate Governance 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 Head of Global Regulatory Affairs and Entity Corporate Governance 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 12-month fixed-term contract for an individual contributor. Key Responsibilities 1. Regulatory Strategy Develop and execute a comprehensive regulatory strategy that al

Job Title: Lead - Aggregate Reporting Employment Type: Full-time Work Type: Remote About ClinChoice: ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis. Our global delivery network has expanded to centers and satellite offices in the United States, Mexico, the United Kingdom, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally. We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision. Primary Responsibilities: Responsible for authoring Aggregate Safety Reports (including but not limited to PBRER/PSUR, ACO, DSUR, PADER, CAR, RMP, Ad-hoc safety reports for medicinal and non-medicinal products and EU-MDR PSUR, PMSR, PMSP, and PRER reports for medical devices, and Cosmetovigilance reports for Cosmetic products for submissions to various health authorities as per the requirement). Plan report-specific timelines, identify relevant stakeholders, request calls for contributions, and coordinate with various stakeholders for obtaining relevant data for the preparation of aggregate safety reports. Review the safety data (including the seriousness and expectedness assessments of events, as may be necessary) as per the agreed strategy and sponsor’s conventions and verify the correctness and completeness of contributions received from stakeholders. Perform aggregate review of post-marketing cases received in global databases and assess whether the cases alter t

Work Flexibility: Hybrid What You Will Do / Roles & Responsibilities As a member of the Global Product Engineering team you will gain in depth knowledge about Stryker’s Trauma & Extremities portfolio. You will learn how Bone Plates & Screws, External Fixators, Surgical Instruments and many other products improve people’s life. Together we are responsible for over 50'000 articles. We count on you to maintain and improve our high standard in design specification and performance. You ensure compliance with applicable regulatory and quality requirements, including FDA, EU MDR, ISO 13485, and internal standards, by driving design change management activities, support regulatory submissions, and serving as a subject matter expert during internal and external audits. In your field of responsibility, you will make sure that design requirements are met as well as apply the design change process and identify technical solutions in this context. You oversee the continuous improvement projects for existing products in our group, create and manage project plans, assign and follow up on work packages. You participate in and at times lead cross functional teams to perform design related Non-Conformities(NC), Corrective- and Preventive-Actions(CAPA). Your role will include frequent contact with other teams such as the international Regulatory Affairs, Tech. Publications, Design Quality or Marketing to address design related questions for international registrations and creations of technical files required for the implementation of EU-MDR requirements. Drive value improvement, design optimization, and continuous improvement initiatives to enhance product performance, quality, compliance, and cost effectiveness. What You Need <

We anticipate the application window for this opening will close on - 29 Sep 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 The Supplier Quality function partners with Contract Manufacturers (CMs), Original Equipment Manufacturers (OEMs), and critical suppliers to ensure the quality, compliance, and performance of externally manufactured products and components. This team works cross-functionally with Research & Development (R&D), Quality, Regulatory Affairs, and Operations to support product lifecycle activities, drive supplier performance improvements, and maintain compliance with applicable quality system and regulatory requirements. This position may be performed remotely anywhere within the United States. Travel up to 15% is required to support supplier audits, supplier performance reviews, business meetings, and cross-functional initiatives. The Senior Supplier Quality Engineer serves as the primary quality partner for strategic Contract Manufacturers and Original Equipment Manufacturers, ensuring supplier processes, products, and quality systems consistently meet Medtronic requirements. This role drives supplier quality performance, supports product and process changes, leads quality improvement initiatives, and provides technical quality guidance across supplier-related activities throughout the product lifecycle. Primary Responsi

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

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is searching for a Labeling Artwork Controller - Consultant in Czech Republic for 12 months Contract with REMOTE option with possibility of extension to join one of our consumer product clients. Role Summary The Regional / Senior Artwork Controller is responsible for managing the end-to-end artwork development process (brief → final release) for packaging and labeling components within the region. This role ensures timely delivery of high-quality, compliant artwork by coordinating cross-functional teams and external vendors, while driving process improvements and maintaining operational excellence. This role combines hands-on execution with team supervision. Key Responsibilities: Manage the end-to-end artwork development process from initiation through approval and release, ensuring timely delivery of high-quality labeling components. Act as the primary liaison between PMO, Regulatory Affairs, Marketing, Packaging, Quality, Supply Chain, and external vendors/agencies. Validate briefs for accuracy and completeness; collaborate with cross-functional teams to resolve discrepancies. Oversee timelines, resource planning, and progress tracking for multiple concurrent labeling projects. Coordinate review and approval of labeling content and artwork in internal systems, ensuring compliance with regulatory, legal, and corporate standards. Drive process improvements related to artwork development, approval workflows, and digital tools. Investigate Root Cause Analyses (RCAs) and implement Corrective and Preventive Actions (CAPA) as needed. Maintain artwork issue logs and attend escalation meetings to provide updates. Identify inefficiencies and escalate to Hub Leads when required. Participate in content lock

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is searching for a Labeling Artwork Controller - Consultant in Italy for 12 months Contract with REMOTE option with possibility of extension to join one of our consumer product clients. Role Summary The Regional / Senior Artwork Controller is responsible for managing the end-to-end artwork development process (brief → final release) for packaging and labeling components within the region. This role ensures timely delivery of high-quality, compliant artwork by coordinating cross-functional teams and external vendors, while driving process improvements and maintaining operational excellence. This role combines hands-on execution with team supervision. Key Responsibilities: Manage the end-to-end artwork development process from initiation through approval and release, ensuring timely delivery of high-quality labeling components. Act as the primary liaison between PMO, Regulatory Affairs, Marketing, Packaging, Quality, Supply Chain, and external vendors/agencies. Validate briefs for accuracy and completeness; collaborate with cross-functional teams to resolve discrepancies. Oversee timelines, resource planning, and progress tracking for multiple concurrent labeling projects. Coordinate review and approval of labeling content and artwork in internal systems, ensuring compliance with regulatory, legal, and corporate standards. Drive process improvements related to artwork development, approval workflows, and digital tools. Investigate Root Cause Analyses (RCAs) and implement Corrective and Preventive Actions (CAPA) as needed. Maintain artwork issue logs and attend escalation meetings to provide updates. Identify inefficiencies and escalate to Hub Leads when required. Participate in content lock meetings

Job Title Site Leader (Director), Operations Quality Assurance- Job Description The Site Leader (Director), Operations Quality Assurance is responsible for leading the Quality function across the Pune (Chakan) manufacturing sites. This role provides strategic and operational leadership to ensure all medical devices, manufacturing processes, and quality system activities comply with applicable regulatory requirements, Philips standards, and business objectives. Your Role: Lead all Operations Quality Assurance activities across the Pune (Chakan) manufacturing sites, ensuring compliance, product quality, patient safety, and operations quality performance. Accountable for developing and executing the Operations Quality Strategy, translating enterprise quality objectives into measurable site-level priorities/results, driving a culture of quality and compliance, ensuring inspection readiness, and continuously improving quality performance across the sites. As the senior Quality leader and designated Quality Management Representative, the Director represents the organization during regulatory inspections/external audits, ensures the effectiveness and compliance of the Quality Management System and partners closely with Operations, R&D, Regulatory Affairs, Supply Chain, and Business Leadership to ensure product quality, patient safety, and business continuity. Ensure all products, manufacturing processes, and quality system activities comply with FDA regulations, ISO 13485, ISO 14971, MDSAP, EU MDR, and other applicable global requirements. Lead and represent the sites during FDA inspections, Notified Body audits, customer audits, and regulatory authority interactions, maintaining a continuous state of inspection readiness. Drive timely resolution of audit findings, compliance gaps, nonconformances, and CAPA act