Senior Regulatory Affairs Specialist in India

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 <

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

This role is responsible for managing billing processes, revenue, and payment collection by ensuring accurate and timely updates on various portals, responds to disputes, and provides detailed financial reporting. Source: Adani Group | Job ID: 56469

Screener is responsible to ensure the safe and efficient screening of hold baggage, ensuring compliance with regulatory standards and the detection of prohibited items or security threats. The Screener will be responsible for operating screening equipment, documenting findings, collaborating with other security staff, and interacting with passengers to maintain the highest standards of security. Source: Adani Group | Job ID: 49118

This role is responsible for overseeing the organization's legal proceedings by handling both regulatoty and non regulatory litigation. The role involves direct management of civil litigations, response to regulatory challenges, and coordination with various business units to support the company's legal position. Source: Adani Group | Job ID: 56699

The Team Member - Fx is responsible for supporting the management of the organization's foreign exchange (FX) risk, assisting in hedging strategies, monitoring global currency markets, and ensuring compliance with regulatory guidelines. The role involves coordinating with internal and external stakeholders to optimize FX transactions and enhance the efficiency of forex operations. Source: Adani Group | Job ID: 55015

Executive - ARFF Training is responsible for assisting in developing, delivering and documenting ARFF training programs to ensure that all ARFF personnel meet operational and regulatory standards. The role focuses on assisting with training schedules, maintaining training records, evaluating trainees and ensuring compliance with ICAO, CAA, and airport-specific requirements. Source: Adani Group | Job ID: 52444

As a Colliery Engineer, the core objective is to oversee and manage various engineering aspects of coal mining operations, ensuring compliance with safety standards, regulatory requirements, and company policies. Key responsibilities include planning, installation, and maintenance of critical infrastructure such as electrical systems, pipelines, and machinery to facilitate safe and efficient mining activities. Additionally, the role involves coordinating monsoon arrangements, water management, and environmental initiatives, while also focusing on budgeting, compliance, and technological advancements to optimize operational efficiency and sustainability. Source: Adani Group | Job ID: 51899

To ensure the security and safety of plant personnel, assets, and infrastructure by implementing effective security protocols, surveillance systems, and regulatory compliance measures at the Mahan plant. Source: Adani Group | Job ID: 53413

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. 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 on the AI Governance Engineering team, you will play a critical role in shaping and building OneTrust's next-generation AI Governance platform. You will help transform complex AI governance, compliance, safety, and agent r

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 Due to rapid growth and increased demand for our Privacy, Security, Data Governance, GRC, Third-Party Risk, Ethics and Compliance, and ESG platform, OneTrust is seeking a Senior UX Designer to join the User Experience Design team within our dynamic Research and Development team. This team continually improves the usability, design, and overall experience of OneTrust offerings, including web applications and other products and services. It is an excellent opportunity to improve the experience of an exceptionally wide range of users around the world. Your Mission The Senior UX Designer will work under the oversight of a Principal UX Designer and assist with all the UX responsibilities below: Design: Create deliverables for the entire design process, including information architecture, interface design, interaction design, and low and high-fidelity prototypes. Standards: Identify, define and promote UX best practices, including templates UX Metrics: Identify, collect, and analyze data to inform user experience decisions, including web metrics, customer sup

Our Purpose Mastercard powers economies and empowers people in 200&#43; countries and territories worldwide. Together with our customers, we’re helping build a sustainable economy where everyone can prosper. We support a wide range of digital payments choices, making transactions secure, simple, smart and accessible. Our technology and innovation, partnerships and networks combine to deliver a unique set of products and services that help people, businesses and governments realize their greatest potential. Title and Summary Senior Auditor Overview: Mastercard's Global Internal Audit team provides independent and objective assurance and advisory services to assess and enhance the effectiveness and efficiency of governance, risk management, and internal control processes. The team is seeking a Senior Auditor based in Pune, India, to support financial, operational, regulatory, and technology audit and advisory engagements. The ideal candidate is initiative-taking, intellectually curious, analytical, meticulous, and able to balance independent delivery with effective collaboration across a global team. Role: • Execute financial, operational, regulatory, technology, and advisory audits across business lines in accordance with Internal Audit methodology and quality standards. • Participate in audit planning, including understanding business processes, assessing risks, contributing to scope and approach, and developing audit procedures. • Independently evaluate the design and operating effectiveness of controls, document high-quality workpapers, and communicate testing status, potential issues, and delivery risks on a timely basis. • Identify control gaps, root causes, and process improvement opportunities; develop practical recommendations that address underlying risks and support sustainable remediation. • Draft

Senior Compliance Specialist Position Description SingleStore is building a real-time data platform that helps organizations transact, analyze and act on data in a single system. We are committed to operating with strong security, privacy and resilience standards across our products, services and internal operations. We are seeking an experienced and highly motivated Senior Compliance Specialist to help scale our security, privacy and compliance programs. This role will be responsible for maintaining key certifications, driving cross-functional compliance initiatives, overseeing development and management of our privacy program, supporting compliance with the Digital Operational Resilience Act (DORA), and helping mature our Business Continuity Management System (BCMS). The ideal candidate is practical, organized and collaborative, with experience translating regulatory and framework requirements into durable operational processes across technical and business teams. Job Responsibilities Support governance activities across the security, privacy and compliance program, including maintaining Information Security Management System documentation, evidence, policies, procedures and audit trails. Help maintain and improve active certifications and attestations such as ISO/IEC 27001, SOC 2 Type II, HIPAA and PCI DSS, while coordinating with stakeholders across the business to ensure ongoing compliance. Drive readiness efforts for new compliance objectives, certifications and customer-driven assurance requirements. Participate in enterprise risk management activities, including risk methodology, risk assessments, treatment planning and follow-up with risk owners. Oversee the development, implementation and ongoing management of SingleStore’s privacy program in partnership with Legal, Security, IT and business stakeholders. Support compliance with applicable privacy and data protection requirements, including operationalizing controls and processes needed to meet regu

About the Job: LaunchDarkly is seeking a Senior International Accountant to manage and coordinate international accounting, reporting, and compliance activities for our subsidiaries’ operations in EMEA, Australia and India. The Senior International Accountant will partner closely with accounting, payroll, tax and external accounting firms to ensure timely and accurate monthly accounting, reporting and international statutory compliance. This role will also act as the local community leader in India for the CFO organization, driving team culture and engagement. Responsibilities: Coordinate with foreign entities' local accountants for timely monthly financial reporting and day-to-day operational activities Manage international month-end close across multiple jurisdictions including EMEA, Australia and India, including review of subsidiaries’ financial package, prepare intercompany journal entries and reconciliation, and prepare flux analyses Review international payment and obtain approvals for bank disbursements Manage international tax, audit and regulatory compliance calendars, ensure adherence to local and international accounting regulations, including various filings, reporting requirements, and statutory deadlines Implement intercompany and multi-book modules in accounting system and perform settlement of intercompany transactions Support international tax structure compliance, including transfer pricing documentation Support relationships with external auditors, tax advisors, and regulatory authorities, including coordination of audits and preparation of supporting requests and documentation Serves as local community leader for the CFO organization in India Qualifications: Bachelor's degree or higher in Accounting, Finance, or a related field required CPA or similar designation is a plus; Big 4 or professional services background strongly preferred 7+ years of progressive accounting experience with significant exposure to international operations and mul