Regulatory Affairs Manager Jobs

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

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: 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

ABOUT THE ROLE The Product Safety and Compliance Engineer supports Peloton's global Technical Product Safety and Regulatory Compliance organization by ensuring components and finished connected fitness equipment sourced from Taiwan and China meet Peloton's safety, quality, and regulatory standards. Based in Taichung, Taiwan, this position serves as Peloton's on-the-ground technical resource for its Asia-based supply chain, requiring up to 30% travel. This role works cross-functionally with Product, Design, Engineering, Global Quality, Legal, and Regulatory Affairs teams to ensure all products are safe, legally compliant, and certification-ready for global markets.This position places a strong emphasis on scalable processes, proactive pre-certification testing, root-cause analysis, and preventive action. Using structured methodologies such as 8D, the Engineer is expected to lead compliance strategies during product development and sustaining activities, resolve the underlying causes of supplier safety issues, and prevent recurrence, rather than applying reactive, short-term fixes. The engineer will also help drive initiatives that elevate product safety beyond baseline regulations throughout the entire product lifecycle. YOUR DAILY IMPACT AT PELOTON Partner with cross-functional teams to manage day-to-day safety and regulatory compliance activities with component suppliers and OEM/ODM manufacturers in Taiwan and China Drive the creation, scoping, scheduling, and execution of test and global certification plans (UL/CSA, CB Scheme, CCC, BSMI/CNS, PSE, CE, FCC/NCC, IC, and EN EMC) Develop pre-certification test strategies to proactively identify, debug, and resolve compliance and safety risks early in the development cycle Review and analyze lab/supplier test reports, certificates of compliance, and technical files for accuracy, completeness, and conformance to international standards Lead root-cause analysis and corrective/preventive action (CAPA) using structured

Job Title: Assistant – Operations Employment Type: Contract (12 months) Location: Bengaluru, India Work Type: Office-based Experience: 1–1.5 years 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 • Biometric & Access Management: Manage biometric attendance systems and employee access control. Activate access for new joiners and deactivate access for exiting employees. Coordinate maintenance and troubleshooting of biometric devices. Maintain and update biometric and access trackers. • CCTV Monitoring & Maintenance: Monitor CCTV systems and ensure proper functioning. Maintain CCTV time synchronization and recording accuracy. Coordinate with vendors/service providers for maintenance and issue resolution. • Security & Housekeeping Coordination: Supervise security and housekeeping operations. Manage attendance and manpower allocation for security/HK staff. Ensure workplace cleanliness, safety, and operation

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

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+ 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

We anticipate the application window for this opening will close on - 25 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+ 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 Neuroscience Portfolio delivers therapies that treat disorders of the brain, spine, nerves, and vascular system. Through a broad range of medical technologies, our teams partner with physicians and healthcare systems worldwide to improve patient outcomes and quality of life. The Neurovascular Operating Unit develops technologies that treat acute ischemic stroke, hemorrhagic stroke, and other neurovascular diseases. Our portfolio includes devices designed to restore blood flow, remove clots, and treat complex vascular conditions, supporting physicians in delivering life-changing therapies to patients worldwide. This role supports the development, maintenance, and continuous improvement of stent-based neurovascular devices within a regulated medical technology environment. The engineering team partners closely with Quality, Manufacturing, Regulatory Affairs, Clinical, Supply Chain, and Marketing functions to ensure product performance, compliance, and lifecycle management are maintained while supporting patient outcomes. This is an onsite position based in Irvine, California. Travel is expected to be less than 10% and may include visits to manufacturing sites, suppliers, or company locations as

To lead and manage corporate affairs initiatives by fostering strong relationships with government authorities, regulatory bodies, industry associations, and external stakeholders. The role is responsible for supporting business objectives through effective stakeholder engagement, policy advocacy, statutory coordination, issue resolution, and ensuring regulatory compliance while safeguarding the organization's reputation and interests. Source: Adani Group | Job ID: 55523

About the Team OpenAI’s mission is to ensure that general-purpose artificial intelligence benefits all of humanity. We believe that achieving our goal requires effective engagement with public policy stakeholders and the broader community impacted by AI. Accordingly, our Global Affairs team builds authentic, collaborative relationships with public officials and the broader AI policymaking community to inform and support our shared work in these domains. We ensure that insights from policymakers inform our work and - in collaboration with our colleagues and external stakeholders - seek to further regulation, industry standards, and safe and beneficial development of AI tools. About the Role As a US Congressional Lead on the Global Affairs team, you will help develop strategies and advance OpenAI’s engagement with the U.S. Congress, including developing and managing relationships with House and Senate lawmakers and staff. You will support OpenAI’s U.S. Global Affairs team in meetings, briefings, hearings and other engagements with Congress. You will also facilitate collaboration with civil society and industry partners relevant to Congressional engagement and in alignment with OpenAI’s mission. OpenAI releases industry-leading research and tools. You will face new challenges as the impact of cutting edge generative AI technologies continues to be explored and as the needs of the organization evolve. Day-to-day work may encompass anything from helping to shape strategic initiatives and policy documents to preparing our leaders for engagements with government officials or representing OpenAI in private and public forums. We are looking for a self-directed and creative individual with Capitol Hill experience, experience managing private sector and civil society relationships, plus an understanding of AI-related legislative and regulatory issues and processes. This role is based in Washington, DC and may require frequent travel to participate in meetings and events with k

The Lead – Corporate Affairs is responsible for supporting government relations, corporate affairs, and regulatory compliance for redevelopment projects. This role involves engaging with government agencies such as BMC and the Collector’s Office, assisting with tenant management, and ensuring smooth execution of approvals and permissions. The position also plays a key role in stakeholder management, crisis resolution, and strategic communication to facilitate project execution. Source: Adani Group | Job ID: 52342

Altana is the network for trusted trade. Our AI-powered product network empowers governments and businesses to build a more resilient and secure global economy while keeping trade flowing. The Opportunity at Altana Director of Government Affairs to lead European Union (EU) government relations efforts. This senior-level position will be responsible for developing and executing strategies to influence public policy, engage with key stakeholders, and ensure that our organization’s interests are represented effectively at the EU level. You Will Develop and implement comprehensive government affairs strategies that align with the company's goals and objectives; monitor and analyze legislative and regulatory developments in the EU that could impact the organization; and provide strategic advice to senior management on policy and regulatory issues. Build and maintain strong relationships with EU institutions, including the European Commission, European Parliament, and Council of the EU; engage with member-state governments, industry associations, and other stakeholders to advocate for the company's positions; and represent the organization at meetings, conferences, and other public forums. Develop and articulate policy positions on key issues affecting the organization; draft position papers, policy briefs, and advocacy materials; and lead lobbying efforts to influence policy and regulatory outcomes. Work closely with internal departments, including marketing, sales, and the product team to ensure cohesive advocacy efforts; and coordinate with external consultants, lobbyists, and industry coalitions to amplify the organization's voice. Communicate complex policy issues and the organization's positions to various audiences, including policymakers, stakeholders, and the public; and prepare and deliver presentations, reports, and other communication materials to senior management and external parties. Ensure compliance with all lobbying and political activity regulations in

End to end responsible for: • government and municipal stakeholder strategy that accelerates project permissions/NOCs/clearances and protects license to operate. • relationship governance, escalation pathways and facilitation support for critical approvals in coordination with Regulatory and Business teams. • disciplined tracking, submission standards and compliance evidence for authority interactions. • protocol management for VIP visits and MoU ceremonies to protect reputation and stakeholder goodwill. Source: Adani Group | Job ID: 53518

Sr. Director of Commercial and Legal Affairs About Backblaze Backblaze is a public company that makes storing and using data astonishingly easy. When our founding team got together, they committed to helping people save their data. Today, the Backblaze Storage Cloud provides a foundational platform around the world for a broad community of developers, IT generalists, entrepreneurs, and individuals who seek the easy, affordable, trusted solutions we provide. We have managed to nurture a team-oriented culture with amazingly low turnover. Our approach is guided by honesty, transparency, and a commitment to doing the right thing. Our customers are happy, and so are our coworkers: in the most recent “Great Place to Work” survey, 97% of our team rated Backblaze as “a great place to work.” Check out what our employees are saying on Glassdoor! About the Role We are seeking a Sr. Director of Commercial and Legal Affairs to lead and oversee Backblaze’s commercial, privacy, and product legal functions. This is a people leader role that will serve as a strategic business partner across Sales, Product, Engineering, Security, and Compliance. The ideal candidate is a highly experienced commercial lawyer with a strong track record of drafting and negotiating complex technology transactions, including enterprise and strategic partnership deals. This role also requires fluency in privacy and data protection issues and hands-on experience advising product and engineering teams throughout the product lifecycle. This position will play a critical role in enabling scalable growth while thoughtfully managing legal and regulatory risk as Backblaze continues to expand globally. This role includes people management responsibilities and will lead, mentor, and develop attorney(s) and legal professional(s) supporting commercial, privacy, and product work. This role reports to the Head of Legal & Compliance and is fully remote (US-based). What You’ll Do Commercial Leadership and Deal Executi

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