Medical Device Reporting Specialist

hace 2 días


San José, San José, Costa Rica Genpact A tiempo completo

**Job Summary:**

Genpact is a global professional services and solutions firm delivering outcomes that shape the future. Our team of experts helps leading enterprises, including Fortune Global 500 companies, achieve their goals through our deep business and industry knowledge, digital operations services, and expertise in data, technology, and AI.

The Medical Device Reporting (MDR) Analyst will play a crucial role in ensuring compliance with regulatory requirements and facilitating the timely and accurate reporting of adverse events and product malfunctions associated with medical devices.

**Responsibilities:**

  • Stay up to date with the latest regulations and guidelines related to medical device reporting, including those issued by regulatory bodies such as the U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA).
  • Representatives within the countries that perform the assessment, creation, and submission of Medical Device Reporting.
  • Coordination and execution of the Medical Device Incident reporting handling process.
  • Timely adverse event reporting.
  • Overall responsibility for making Medical Device Reporting decisions.
  • Managing Health Authority Requests.

**Requirements:**

  • In-depth knowledge of medical device regulations and guidelines (e.g., FDA, EMA, ISO 13485).
  • Medical devices complaint handling experience.
  • Experience working with complaint management systems as EtQ and/or Sales Force based software.
  • Familiarity with adverse event reporting requirements and processes.


  • San José, San José, Costa Rica Genpact A tiempo completo

    Job DescriptionGenpact is a global professional services and solutions firm delivering outcomes that shape the future. Our 125,000+ people across 30+ countries are driven by our innate curiosity, entrepreneurial agility, and desire to create lasting value for clients. Powered by our purpose – the relentless pursuit of a world that works better for people...


  • San José, San José, Costa Rica Gsb A tiempo completo

    At Gsb, we are seeking a highly skilled Medical Device Validation Specialist to join our team. In this role, you will be responsible for guiding the Engineering Manager (EM) through the validation process, leading the draft and review of protocols and test reports.We are looking for a candidate with 3+ years of experience in the Medical Device Industry, who...


  • San José, San José, Costa Rica Microport Orthopedics S.A. A tiempo completo

    Job DescriptionThe Medical Device Surveillance Specialist will play a crucial role in ensuring the compliance and safety of Microport Orthopedics' medical devices. The ideal candidate will have a strong background in engineering, regulatory affairs, or a related field.Responsibilities:Conducting post-market surveillance activities in accordance with company...


  • San José, San José, Costa Rica Genpact A tiempo completo

    **About Us:**At Genpact, we're dedicated to helping businesses achieve their goals through our expertise in digital operations, data, technology, and AI.We're seeking an experienced Medical Device Reporting (MDR) Specialist to join our team. In this role, you'll be responsible for managing and coordinating all aspects of medical device reporting, ensuring...


  • San José, San José, Costa Rica Theragenics Costa Rica Ltd. A tiempo completo

    Job SummaryWe are seeking a highly experienced Quality Assurance Specialist to join our team at Theragenics Costa Rica Ltd. In this role, you will be responsible for providing quality assurance support to our production processes, initiatives, and projects.Main Responsibilities:Quality Assurance Support: Provide experienced quality assurance support to...


  • San José, San José, Costa Rica Gsb A tiempo completo

    Job Overview:We are seeking a highly motivated and experienced Validation Engineer to join our team at Gsb. As a key member of our organization, you will be responsible for ensuring the quality and safety of our medical devices.About the Role:Develop and implement validation strategies to ensure compliance with regulatory requirements.Liaise with...


  • San José, San José, Costa Rica Gsb A tiempo completo

    About the JobGsb is looking for a highly skilled Validation Engineer to join their team in Costa Rica. This 9-month project offers the possibility of extension.The ideal candidate will have experience in process/equipment validation and technical support, with a strong background in the Medical Devices industry.Key Responsibilities:Develop strategies and...

  • Management Trainee

    hace 3 semanas


    San José, San José, Costa Rica Genpact A tiempo completo

    Genpact (NYSE: G) is a global professional services and solutions firm delivering outcomes that shape the future.Our 125,000+ people across 30+ countries are driven by our innate curiosity, entrepreneurial agility, and desire to create lasting value for clients.Powered by our purpose – the relentless pursuit of a world that works better for people – we...

  • Adverse Event Manager

    hace 6 días


    San José, San José, Costa Rica Genpact A tiempo completo

    Job SummaryThe Medical Device Reporting Analyst will be responsible for coordinating and executing medical device reporting activities within the organization. This includes managing the reporting process, conducting investigations, and providing support to cross-functional teams.Duties and ResponsibilitiesDevelop and maintain accurate and complete...


  • San José, San José, Costa Rica Genpact A tiempo completo

    **Company Overview:**Genpact is a global professional services and solutions firm that delivers outcomes that shape the future. Our team of experts helps leading enterprises, including Fortune Global 500 companies, achieve their goals through our deep business and industry knowledge, digital operations services, and expertise in data, technology, and AI.The...


  • San José, San José, Costa Rica Pfizer A tiempo completo

    Job Purpose:We are seeking a highly skilled Medical Content Specialist to join our team at Pfizer. The ideal candidate will have a strong background in pharmaceutical science and excellent writing skills.Main Responsibilities:Content Development: Develop high-quality medical content across various channels and formats, leveraging scientific expertise and...


  • San José, San José, Costa Rica Genpact A tiempo completo

    About the RoleWe are seeking an experienced Medical Device Reporting Analyst to join our team at Genpact. As a key member of our regulatory compliance department, you will be responsible for ensuring the accuracy and timeliness of medical device reports submitted to regulatory authorities.Key ResponsibilitiesDevelop and implement procedures for managing...


  • San José, San José, Costa Rica Pfizer A tiempo completo

    Job SummaryPfizer's Global Medical Surveillance Team plays a vital role in ensuring the safe and effective use of medicines. As a Medical Surveillance Specialist, you will be responsible for monitoring and analyzing adverse event reports to identify potential safety risks.Your Key Responsibilities:Monitor and evaluate adverse event reports received from...


  • San José, San José, Costa Rica Msd A tiempo completo

    **Associate Specialist, Accounting to Reporting**The Associate Specialist Accounting to Reporting will be accountable and responsible for ensuring that the transactions of all the markets that the BSC - AMER in Costa Rica have been properly accounted for and accurately reflect accounting process.The objective of this role is to work closely with Local...


  • San José, San José, Costa Rica Zimvie A tiempo completo

    Welcome to ZimVie, a global leader in medical devices. We are dedicated to improving the quality of life for our patients through innovative solutions.Job SummaryThis position is responsible for supporting the complaint handling unit by assessing complaints for reportability to regulatory authorities. The successful candidate will execute based on the...


  • San José, San José, Costa Rica Boston Scientific Corporation A tiempo completo

    **Unlock Your Potential at Boston Scientific Corporation**We are seeking a highly motivated and enthusiastic individual to join our team as an intern in our medical devices company. As a Business Development Intern, you will have the opportunity to gain hands-on experience in business development, working closely with our experienced professionals to drive...


  • San José, San José, Costa Rica Pfizer A tiempo completo

    About Pfizer: Bringing Breakthroughs That Change LivesWe are seeking a highly motivated individual to join our team as a Medical Meeting Support Specialist. In this role, you will support the MAPP Center department in ensuring compliance with anti-bribery and anti-corruption internal policy and addressing bribery and corruption risks in our interactions with...


  • San José, San José, Costa Rica Smith+Nephew A tiempo completo

    Job DescriptionThe Microbiology & Sterilization Intern will gain experience by assisting the Microbiology and Sterilization team with supporting Microbiology laboratory and equipment validation activities. This includes learning about manufacturing processes, tracking and collecting samples for validation or microbiological testing purposes, reviewing...


  • San José, San José, Costa Rica Infotree Global Solutions A tiempo completo

    About the JobAt Infotree Global Solutions, we are seeking a highly skilled Senior Financial Reporting Specialist to join our team. This is a contract position for 03 months with a salary range of ¢550,000.00 - ¢600,000.00 per month.ResponsibilitiesProvide financial reporting support to the data network team.Develop high-level models to estimate savings...


  • San José, San José, Costa Rica Te Connectivity A tiempo completo

    **Job Summary:**We are seeking a detail-oriented Financial Reporting Specialist to join our team. The ideal candidate will have 1+ years of experience in General Accounting or Accounts Payable/Receivable and proficiency in English.Key Responsibilities:Support the migration of R2R processes from countries in scopePrepare process documentation (process maps...