Regulatory Affairs Cmc Associate Jobs

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 Description Job Title: Medical Reviewer Employment Type: Contract Location: Brazil Experience – 2 to 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 centres 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: Awareness and understanding of relevant GVP modules. Perform medical review of non-serious & serious ICSRs with emphasis on seriousness, expectedness, causality & narrative etc. without missing on quality & compliance. Experience of medical review of ICSRs received from sources such as Spontaneous, Literature, Regulatory Authority, Solicited and Clinical trials. Experience across multiple therapeutic areas such as Oncology, Respiratory, Immunology, Neuroscience, Rare diseases etc. Support triage of cases and determine seriousness and relatedness across products as assigned. Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labelling and review narrative. Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas. Involve in process improvement

Responsible for the scientific and clinical oversight of clinical trials in support of the development strategy for programs within the Inflammation & Immunology (I&I) portfolio. As an individual contributor, this role focuses on ensuring data integrity and quality for clinical trials across both early and late-stage development, based on portfolio and resourcing needs. The Senior Manager partners with other clinical and medical colleagues, clinical operations, and other functional lines for the successful implementation and execution of the clinical trial(s) within the assigned program. This role is central to ensuring studies are conducted with the highest scientific and ethical standards. The role is also expected to leverage AI tools and other innovative technologies to improve ways of working, enhance efficiency, reduce work redundancy and improve quality. JOB RESPONSIBILITIES Maintains current scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment. Authors and reviews key clinical and regulatory documents including, but not limited to, protocols, study-level informed consent forms (ICFs), Investigator's Brochures (IBs), clinical study reports (CSRs), and regulatory submission components. Leads the clinical data review strategy, including the ongoing review of emerging clinical data for safety and efficacy trends. Presents relevant data to internal teams, governance bodies, and other stakeholders. Collaborates with cross-functional team members (e.g., Clinical Operations, Biostatistics, Regulatory Affairs, Clinical Pharmacology) to ensure trial objectives are met and activities are executed seamlessly. Provides scientific and clinical input for site training materials and supports responses to questions from investigators and site personnel regarding the protocol and study conduct.

POSITION SUMMARY: Join Natera as the Director of Development for our Early Cancer Detection (ECD) In Vitro Diagnostic (IVD) products. You will take ownership of the development, verification, and validation of our early cancer detection (ECD) Next Generation Sequencing products from feasibility exit through regulatory submission and post-market support. Every test represents a real person, and you will lead a team of scientists and managers to execute the performance data packages supporting PMA submissions. You will serve as the technical subject matter expert in FDA interactions, partnering across functions to deliver design-controlled diagnostic products that directly impact patient care. PRIMARY RESPONSIBILITIES: Own the execution of the technical strategy and phase-gated process of of development, design verification, and validation studies for ECD IVD devices utilizing cfDNA, methylation and other potential analytes Ensure rigorous compliance with applicable FDA Class III (PMA) design and development requirements Take ownership of the analytical performance strategy (limit of blank/detection, precision, linearity, interference, stability) for ECD assays, partnering directly with Regulatory Affairs (RA), biostatistics, bioinformatics and research teams Contribute to the robust transfer of assays to the commercial laboratory and manufacturing in support of the design transfer and operations teams Partner with clinical and biostatistics leaders on statistical analysis plans required for approvable device performance claims in clinical intended-use populations Think team by partnering directly across bioinformatics, biostatistics, software engineering, clinical, regulatory, and commercial functions to align development efforts with business goals, and drive resourcing and go/no-go recommendations at phase gates Deliver the analytical performance data package supporting Class III PMA submissions, developing a comprehensive approval strategy with RA Serve as t

ClinChoice is a global full-service CRO committed to professional growth and a quality-driven “one-team” culture. We are seeking a Senior/ Principal Statistician to join our in-house team and support projects across a diverse client portfolio, including pharmaceutical, biotechnology, medical device, and consumer health companies of varying sizes. We are seeking an experienced Senior/Principal Statistician Consultant to provide statistical leadership and expertise across clinical development programs within the pharmaceutical industry. The successful candidate will contribute to clinical trial design, statistical methodology, data analysis, and regulatory submissions while collaborating with cross-functional teams to support evidence generation and informed decision-making throughout drug development. Key Responsibilities Provide statistical leadership across clinical development programs, from early-phase studies through late-phase clinical trials. Lead clinical trial design, including endpoint selection, sample size calculations, power analyses, and randomization strategies. Develop and review clinical study protocols, statistical analysis plans (SAPs), and other statistical documentation. Oversee statistical analyses and interpretation of clinical trial data to ensure scientific rigor and regulatory compliance. Provide statistical expertise for regulatory submissions and interactions with health authorities, including the FDA and EMA. Collaborate with Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, and Medical Writing teams. Review statistical outputs, including tables, listings, and figures (TLFs), to ensure accuracy and consistency with analysis plans. Apply appropriate statistical methodologies to address complex clinical trial design and analysis challenges. Contribute to clinical study reports (CSRs), integrated summaries of safety and efficacy, and other regulatory documents. Identify statistical risks and recommend appropriat

ClinChoice is a global full-service CRO committed to professional growth and a quality-driven “one-team” culture. We are seeking a Senior/ Principal Statistician to join our in-house team and support projects across a diverse client portfolio, including pharmaceutical, biotechnology, medical device, and consumer health companies of varying sizes. We are seeking an experienced Senior/Principal Statistician Consultant to provide statistical leadership and expertise across clinical development programs within the pharmaceutical industry. The successful candidate will contribute to clinical trial design, statistical methodology, data analysis, and regulatory submissions while collaborating with cross-functional teams to support evidence generation and informed decision-making throughout drug development. Key Responsibilities Provide statistical leadership across clinical development programs, from early-phase studies through late-phase clinical trials. Lead clinical trial design, including endpoint selection, sample size calculations, power analyses, and randomization strategies. Develop and review clinical study protocols, statistical analysis plans (SAPs), and other statistical documentation. Oversee statistical analyses and interpretation of clinical trial data to ensure scientific rigor and regulatory compliance. Provide statistical expertise for regulatory submissions and interactions with health authorities, including the FDA and EMA. Collaborate with Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, and Medical Writing teams. Review statistical outputs, including tables, listings, and figures (TLFs), to ensure accuracy and consistency with analysis plans. Apply appropriate statistical methodologies to address complex clinical trial design and analysis challenges. Contribute to clinical study reports (CSRs), integrated summaries of safety and efficacy, and other regulatory documents. Identify statistical risks and recommend appropriat

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

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Senior Associate, Aggregate Reporting Physician on a permanent basis. Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career! Position Overview: The Senior Associate, Aggregate Reporting Physician position is responsible for developing, reviewing, and maintaining high-quality safety and pharmacovigilance documents that support the safety surveillance and regulatory compliance of consumer health products. It requires the ability to synthesize data from multiple sources, including individual case safety reports (ICSRs), aggregate safety data, clinical studies, epidemiological research, literature reviews, post-marketing surveillance, signal detection activities, and other safety data sources. The successful candidate will transform complex safety information into clear, concise, and scientifically accurate documents that support global pharmacovigilance activities and regulatory submissions and will work closely with Drug Safety, Medical Affairs, Regulatory Affairs, Clinical Development, Quality, and R&D teams to ensure consistent, evidence-based communication of product safety information. Main Job Tasks and Responsibilities: Prepare, review, and maintain pharmacovigilance and risk management documents for consumer health products. Synthesize safety information from multiple sources, including: Individual Case Safety Reports (ICSRs), Aggregate safety data analyses, Clinical trial safety data, Post-marketing surveillance data, Epidemiology studies, Published literature, Signal detection and evaluation activities, Benefit-risk assessments, Health Authority Assessment Reports.

What is JetZero ? Today’s aircraft contribute around 4% of global CO2 emissions, equivalent to the emissions of 200 million cars. This is only going to increase: Air travel is forecasted to double by 2050, while meaningful efficiency gains using current airplanes have hit a wall. JetZero is developing a b lended - wing body (BWB) aircraft . It uses up to 50% less fuel and will be built to accommodate zero-emission hydrogen propulsion. JetZero is the inevitable solution to sustainable air travel. The JetZero Team We are experienced aerospace professionals and engineers, excited about the future. That future will only be possible if we share our vision and what it means to people’s lives: carbon-free flight that ' i s better for both passengers and airlines around the world . The Manager, Maintenance Programs leads a team responsible for developing, authoring, and managing the full ecosystem of maintenance programs and requirements for commercial transport aircraft. This role serves as the technical authority for translating airworthiness standards and design intent into structured, certification-compliant maintenance programs, from initial requirements development through entry into service and beyond. The Manager, Maintenance Programs champions the integration of a digital thread across the maintenance ecosystem, ensuring that maintenance data, requirements, and program documentation are connected, traceable, and actionable from design through operations. This leader partners closely with Design Engineering, Regulatory Affairs, and airline customers to ensure the aircraft is designed for maintainability and supported by a world-class maintenance program. Key Responsibilities Team Leadership Lead and manage a team of maintenance program professionals, providing technical direction, mentorship, and workload oversight across multiple aircraft programs. Maintenance Program Ecosystem Own the development and authorship of the aircraft's

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 DESCRIPTION: About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. 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 will have access to: • Career development with an international company where you can grow the career you dream of . • We are committed to bringing the benefits of our trusted medicines to more people in the world’s fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology, women's health, cardiometabolic, pain management/central nervous system, and respiratory. • 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. The Opportunity This position works out of our Kyiv, Ukraine location in the EPD division. What will you do: Review Certificates of Analysis (CoA) for accuracy and compliance with requirements; coordinate with Quality and Regulatory Affairs departments. Manage the price maintenance and update process. Handle distribution-related complaints and coordinate their resolution. Review and verify shipping documents with warehouses and carriers before product dispatch, ensuring uninterrupted product flow. Ensure proper documentation management (credit notes, invoic

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. Your role at Baxter Are you ready to make a significant impact in the field of materials characterization? Baxter's Infusion Technology and Platforms R&D is seeking a dynamic and innovative Research Scientist II to spearhead cutting-edge extractables and leachables (E&L) studies. This role, based in Round Lake, Illinois, offers the opportunity to collaborate with top-tier scientists and drive innovative E&L studies in a fast-paced environment. What You’ll Be Doing As a Research Scientist II you will be responsible for designing and executing E&L studies supporting medical devices, pharmaceutical products, and combination products. You will provide strategic direction, technical oversight, and resource planning while ensuring alignment with industry standards, regulatory requirements, and business objectives. Working across R&D, Regulatory Affairs, Toxicology, Quality, and external laboratories, you will drive the development of scientifically sound and regulatory-compliant E&L programs that support

Job Title META Clinical Application Specialist Job Description Job title: Clinical Application Specialist Your role: Develops and delivers clinical education sessions to customers, adhering to established organization’s standards, guidelines, and product-specific training materials. • Advises customers on the implementation of optimal clinical procedures and protocols to maximize the effectiveness and efficiency of the provided equipment. • Provides first and second-line support to clinical support associate specialists and customers, offering guidance and expertise when additional knowledge or experience is required. • Works under general supervision and established processes, utilizing independent judgment to navigate and adhere to operational policies, ensuring compliance and optimal performance. • Applies analytical skills to resolve medium complexity requests efficiently, exercising judgment within defined procedures and practices to determine appropriate actions that align with organizational goals and objectives. • Participates in customer escalations, complaints (both safety and non-safety related), and feedback processes, following agreed-upon protocols to accurately capture information and manage associated actions. • Collaborates with cross-functional teams, including product development, quality assurance, and regulatory affairs, to address customer concerns and enhance product performance. • Develops and maintains a deep understanding of organization’s products, clinical applications, and relevant industry standards to effectively support customers and provide informed recommendations. • Contributes to continuous improvement initiatives within the service organization, identifying opportunities to streamline processes, enhance service delivery, and optimize customer satisfaction. • Engages in moderately complex clinical or syst

At Freddie Mac, our mission of Making Home Possible is what motivates us, and it’s at the core of everything we do. Since our charter in 1970, we have made home possible for more than 90 million families across the country. Join an organization where your work contributes to a greater purpose. Position Overview: Are you looking for a career that enables you to bring your technology and operations expertise to influence and develop tools / solutions that will improve an organizations Identity Governance capability? Freddie Mac is seeking a creative hands-on IAM Senior Developer to be a member of the Identity and Access Management (IAM) team within the Enterprise Business Technology Operation (BTO) organization. You will be working to build innovative solutions for improving our operational efficiency through automation, increasing user satisfaction with improved user experiences and helping to modernize our technology stack by leveraging SailPoint,AWS/Cloud native technologies. Our Impact: The Enterprise BTO organization enables business operational excellence through the flexible use of technology. The department provides IT strategic services (software development, enhancements, and production support) to support the needs of the Enterprise groups - External Relations and Corporate Communications, Finance, Human Resources, Internal Audit, Legal, Operational Resilience, and Regulatory Affairs. This role will be focused within IAM and often have intersections with the other above listed business lines. Delivery of IAM solutions to enable self-service capabilities Delivery of integrations between IAM systems and other systems Collaboration with other technology teams to advance our technical capabilities, automate and optimize processes to meet business challenges. Your Impact: Be an active member of multiple high-performing teams. Provide technical leadership, contributions and identify trends, patter

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&#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 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