Regulatory Affairs Cmc Associate Jobs

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. The Opportunity This Regulatory Affairs Manager – APAC position will work on-site at our Alameda, CA location in the Diabetes Care Division. We’re focused on helping people with diabetes manage their health with life-changing produc

Regulatory Affairs Specialist, Medical Device — Vietnam - Hanoi. Apply via Workday.

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

Noctrix Health is redefining the treatment of chronic neurological disorders with clinically validated therapeutic wearables. Our team of medical device specialists, neuroscientists, and consumer electronics engineers is dedicated to delivering prescription-grade therapy with an outstanding user experience. We have pioneered the world’s first drug-free wearable therapy, clinically proven to alleviate symptoms in adults with drug-resistant Restless Legs Syndrome (RLS). Join us in transforming healthcare, improving lives, and driving meaningful change through innovative medical technology. We are seeking an experienced and highly organized Manager, Regulatory Affairs to lead and execute regulatory activities supporting the development, registration, commercialization, and post-market compliance of Noctrix Health’s medical devices. This role will help ensure regulatory strategies and deliverables are executed accurately, compliantly, and on schedule throughout the product lifecycle. The Manager, Regulatory Affairs will work closely with Clinical Affairs, Quality, Engineering, Operations, Marketing, and external regulatory partners to provide regulatory guidance, manage submissions, assess product changes, maintain global registrations, and support post-market regulatory activities. The ideal candidate combines strong medical device regulatory expertise with excellent project management skills and the ability to independently drive complex regulatory initiatives across multiple functions. This position reports to the Senior Vice President, Clinical & Regulatory Affairs . This is a full-time, hybrid position that is located at our Pleasanton headquarters. Responsibilities: Provide regulatory guidance to cross-functional teams supporting new product development, design changes, risk management, commercialization, and product lifecycle activities Perform and maintain regulatory assessments for product modifications, soft

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, Regulatory Affairs (ONSITE) on a permanent basis at Cincinnati, OH . Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career! J ob Title: Senior Associate, Regulatory Affairs Employment Type: Full Time Location: Hybrid (Cincinnati, Ohio) - Location Address: 4545 Creek Rd Blue Ash, OH 45242 Responsible for managing, planning, preparation, and delivery of documents both electronic- and paper-based in support of assigned. global regulatory product registrations, renewals, tenders/customs, etc. Coordinate the preparation and submission of medical device applications by providing regulatory information and documents and following up closely on queries from inspection through approval. Prepare and/or review letters of authorization, cover letters for registration certificates, declarations, power of attorney, and other regulatory documentation to ensure accuracy, appropriateness, and consistency of documents intended for various global regulatory submissions. Submit and manage applications for the US FDA Certificates to Foreign Government (CFGs). Maintain various tracking tools to ensure up-to-date information and traceability of all regulatory data/documentation. Perform and/or coordinate legalization, notarization, and apostille of regulatory documents Ensure compliance with current good documentation practices, including but not limited to proofreading, formatting, indexing and recordkeeping. Assist all regions in answering inquiries and providing required documents and information utilizing various search tools and systems. Perform document filing and retrieval functions as directed and per company’s policies and pro

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

Join us as Regulatory Affairs & Project Manager to drive the success of Qonto's regulatory initiatives and support our continued development across Europe. Your mandate: Manage strategic regulatory projects, build trusted relationships with our banking supervisors, animate Qonto's internal governance and turn evolving requirements into clear and actionable plans. You will report to Alex Tribolet, Head of Regulatory, and join a Regulatory team of 15+ professionals within the Risk & Compliance department. ➡️ What you'll do Coordinate strategic regulatory projects: Drive regulatory initiatives from scoping to delivery, coordinating multiple contributors and maintaining a high level of quality within ambitious timelines. Strengthen supervisory relationships: Act as a key point of contact for the ACPR and Qonto's branch supervisors, building constructive relationships and ensuring clear, reliable and timely communication. Turn requirements into action: Translate complex expectations into practical implementation plans and support internal teams through delivery. Represent Qonto with impact: Adapt and simplify complex information for external supervisors, executives and cross-functional stakeholders while maintaining accuracy and credibility. ➡️ What we're looking for Regulatory Affairs foundation: You have around 2–3 years of experience in Regulatory Affairs or Compliance within a traditional bank, a consulting firm or a regulated fintech, with exposure to banking supervisors or strategic regulatory assignments. Project management: You enjoy bringing structure to complex initiatives, coordinating several workstreams and helping teams deliver efficiently within demanding timelines. Push for Excellence: You take pride in producing accurate, thoughtful and high-quality work and continuously look for ways to raise the bar. Communication: You represent Qonto professionally and can adapt, simplify and make complex information accessible to a wide range of audiences. Ownership

Deputy General Manager - Regulatory for AGEL Source: Adani Group | Job ID: 49743

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 Regulatory Affairs Associate Consultant for 12 months Contract with possibility of extension to join one of our clients. ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts. Job Title ANALYST REGULATORY AFFAIRS Consultant Job Summary Ensures proper submission and approvals for market licenses including new registrations, changes and timely renewals, and establishment registrations, organizing and balancing a multitude of projects simultaneously. Scope Major Roles and Responsibilities Elaborate regulatory strategy and execute submission of changes, new registrations and renewals in timely manner with some guidance. Execute activities to obtain or update establishment registration licenses. Execute post-approval activities such as preparation of communications to stakeholders, labels and Instructions for Use and system updates. Request and follow-up of documentation to prepare registration dossiers. Supports regional team on product submissions schedules, prioritization, and pipeline management. Support internal and external audits with documentation requests. Interacts with other stakeholders, government agencies in a professional, decisive, & articulate manner. Act as a point of contact for stakeholders to support business plans and regulatory needs. Review labels compliance in internal system. · Support projects as representative of the subject/country. · Elaborate procedures of the ar

re 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 Regulatory Affairs Associate Consultant for 12 months Contract with possibility of extension to join one of our clients. ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts. Regulatory Affairs Jr. Specialist Consultant / Especialista Jr. de Asuntos Regulatorios Location / Ubicación: Ciudad de México, México Position Summary / Resumen del puesto: Support the preparation, review and follow-up of regulatory submissions for medical devices, ensuring compliance with applicable regulations before health authorities such as COFEPRIS, enabling timely approvals and maintenance of product registrations. Apoyar en la preparación, revisión y seguimiento de trámites regulatorios para dispositivos médicos, asegurando el cumplimiento de la normativa aplicable ante la autoridad sanitaria COFEPRIS, facilitando la obtención y mantenimiento de los registros sanitarios. Key responsabilities / Responsabilidades principales: Prepare and compile regulatory documentation for COFEPRIS submissions (registrations, renewals, changes). Follow up on submissions with regulatory authority (COFEPRIS). Support interpretation of local and international regulations. Support coordination of requests and activities with cross-functional teams. Maintain updated regulatory files and databases. Preparar y compilar documentación regulatoria para sometimientos ante COFEPRIS (registros, renovaciones, modificaciones). Dar seguimiento a los trámites ante autoridad regulatoria (COFEPRIS). Apoyar en la interpretaci

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 122,000 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 cathe

Regulatory Affairs Manager – Heart Failure (on-site) — United States - California - Pleasanton. Apply via Workday.

Regulatory Affairs Intelligence Specialist — United States - Minnesota - St. Paul. Apply via Workday.

Regulatory Affairs Specialist II — United States > Lake Forest : CP01. Apply via Workday.

Regulatory Affairs Specialist — 4 Locations. Apply via Workday.