Medical Device UDI Labeling Expert

hace 2 semanas


Madrid, Madrid, España Vision Achievement A tiempo completo

Job Summary: We are seeking a detail-oriented Medical Device UDI Labeling Specialist to support our client organization in achieving compliance with global UDI requirements.

Overview: Vision Achievement is looking for an experienced expert to lead the implementation of UDI-compliant labeling solutions for medical devices. The ideal candidate will have a deep understanding of global regulatory requirements, including those mandated by the FDA, EU MDR/IVDR, and other international frameworks.

About the Job: As a Medical Device UDI Labeling Specialist, you will be responsible for designing and implementing UDI labels for medical devices, ensuring compliance with global regulatory standards. You will work closely with cross-functional teams to gather label content, including device identifiers, production information, and regulatory symbols. Your expertise will ensure that labels meet global standards such as GS1, HIBC, and ICCBBA specifications.

Your Key Responsibilities:

  • Design and implement UDI labels for medical devices
  • Collaborate with cross-functional teams to gather label content
  • Ensure labels meet global standards
  • Stay up-to-date on UDI regulations for all applicable regions
  • Conduct audits of existing labeling to identify and address non-compliance
  • Work with IT and quality teams to implement and maintain labeling systems
  • Test and validate label designs
  • Create and maintain comprehensive documentation
  • Provide support for internal and external audits
  • Train internal teams on UDI labeling processes

Requirements: To be successful in this role, you will need:

Bachelor's degree in Regulatory Affairs, Engineering, Life Sciences, or a related field

Proven experience with UDI labeling for medical devices

Hands-on experience with labeling software

Strong knowledge of global UDI standards

Proficiency in data management and ERP systems

Exceptional attention to detail and organizational skills

Strong communication and collaboration abilities

$120,000 - $150,000 per year, depending on experience


  • Medical Device Expert

    hace 2 semanas


    Madrid, Madrid, España Sgs A tiempo completo

    Job OverviewAs a highly skilled Medical Device Expert, you will be responsible for conducting thorough assessments of Cardiovascular and Soft Tissue products. This role involves ensuring that technical file reviews adhere to all applicable requirements, including the European Medical Device Regulation (MDR), Medical Device Directive (MDD), and UKCA for Class...


  • Madrid, Madrid, España Cpl Healthcare A tiempo completo

    Exciting Opportunity in Regulatory AffairsCpl Healthcare is seeking an experienced Regulatory Affairs Director to lead our medical device lifecycle management efforts. This is a full-time, permanent position based in Madrid, Spain.About the RoleIn this role, you will be responsible for strategic lifecycle management of our medical devices post-CE approval...


  • Madrid, Madrid, España Abbott Laboratories A tiempo completo

    Responsibilities:The Medical Device Support Expert will be responsible for providing technical support to customers and sales representatives across the region. This will involve traveling extensively (approximately 25% of the time) to visit customers and provide training on our medical devices. The ideal candidate will have a strong background in biomedical...

  • Medical Governance Expert

    hace 3 semanas


    Madrid, Madrid, España Internetwork Expert A tiempo completo

    Exciting Opportunity at Internetwork ExpertWe are seeking a highly skilled Medical Governance Expert to join our team in the Consumer Healthcare division. This is an exciting opportunity for someone who is passionate about ensuring compliance with European healthcare regulations and industry standards.Key Responsibilities:Develop, implement, and maintain...


  • Madrid, Madrid, España Sgs A tiempo completo

    Job SummaryWe are seeking a highly skilled Medical Device Clinical Expert to join our team at Sgs. As an In-house Clinician, you will play a key role in the clinical assessment of medical devices and ensure compliance with EU MDR regulations.About the RoleYou will be responsible for providing clinical oversight and expertise to support the conformity...


  • Madrid, Madrid, España Norgine A tiempo completo

    At Norgine, our employees Dare to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community. We call it the 3D career at Norgine and it offers a fully-rounded experience with no limits.We are looking for a Regulatory Labeling Expert Lead to join our team in any of our locations. The successful...


  • Madrid, Madrid, España Cpl Healthcare A tiempo completo

    Job Overview: An exciting opportunity to join Cpl Healthcare, a growing pharmaceutical company specializing in Cancer and Supportive Care, Gastroenterology, and Hepatology. Due to increasing growth, the business is seeking an Associate Director, Regulatory Affairs - Medical Device Lifecycle Management to join the team.Salary: Attractive salary and package,...


  • Madrid, Madrid, España Shockwave Medical, Inc. A tiempo completo

    Job DescriptionThe Medical Device Territory Sales Lead will be responsible for building and managing a direct sales force in Spain, driving revenue growth and customer satisfaction. This role will work closely with Marketing, R&D, and the Director of International Sales and Distribution to identify market needs and execute on the sale/commercialization of...


  • Madrid, Madrid, España Applied Medical A tiempo completo

    About UsApplied Medical is a leading medical device company committed to innovation and patient care. Our rapid business growth and global expansion make us an exciting opportunity for driven professionals.


  • Madrid, Madrid, España Sgs A tiempo completo

    Job OverviewAt SGS, we are seeking an experienced Medical Device Specialist to join our team. This is a challenging role that requires strong technical expertise and excellent communication skills.About the RoleThe successful candidate will be responsible for conducting comprehensive assessments of Cardiovascular and Soft Tissue products, ensuring technical...


  • Madrid, Madrid, España Sgs A tiempo completo

    Company OverviewWe are SGS, a global benchmark for sustainability, quality, and integrity. With 99,600 employees operating in over 2,600 offices and laboratories, we enable a better, safer, and more interconnected world.Job SummaryAs a Medical Device Assessor at SGS, you will be responsible for conducting comprehensive assessments of Cardiovascular and Soft...


  • Madrid, Madrid, España Applied Medical A tiempo completo

    Are you passionate about delivering exceptional customer experiences in the clinical and surgical setting? If integrity and self-motivation are your strengths, we have an exciting opportunity for a Medical Device Sales Representative.This dynamic field position involves engaging with clinical and administrative hospital staff to understand their needs and...


  • Madrid, Madrid, España Boston Scientific A tiempo completo

    About the OpportunityWe are currently seeking an experienced Medical Device Product Owner to join our team in the EMEA region. As a product owner, you will be responsible for defining and prioritizing product features, working closely with cross-functional teams to deliver high-quality products that meet customer needs.You will be responsible for managing...


  • Madrid, Madrid, España Medtronic A tiempo completo

    Unlock a fulfilling career in medical device commercial excellence with Medtronic, where innovation and purpose converge. As a Medical Device Commercial Excellence Specialist, you will lead the charge in driving sales growth, data-driven insights, and stakeholder engagement. Your journey begins with our Sales Enablement & Excellence team, where collaboration...


  • Madrid, Madrid, España Empresa Reconocida A tiempo completo

    Job DescriptionWe are seeking a skilled Compliance Labeling Specialist to join our team at Empresa Reconocida. In this role, you will play a crucial part in ensuring that all product labeling and instructions for use comply with federal, state, and local regulations.


  • Madrid, Madrid, España Medtronic A tiempo completo

    **About Medtronic** Medtronic is a rapidly growing international healthcare company that offers a competitive salary and flexible benefits package. As a Medical Device Specialist - Pelvic Health Expert, you will play a vital role in providing expert technical support to physicians in the operating room and Cath labs in hospitals during Sacral...


  • Madrid, Madrid, España Institut Straumann Ag A tiempo completo

    Institut Straumann Ag is a global leader in tooth replacement and orthodontic solutions. Our company unites international brands that stand for excellence, innovation, and quality in dentistry.We are seeking a Medical Device Quality Assurance Specialist to join our Supply Chain Compliance team. As a member of this team, you will ensure the conformity and...


  • Madrid, Madrid, España Boston Scientific A tiempo completo

    Company OverviewBoston Scientific is a global leader in the medical device industry, dedicated to delivering innovative solutions that improve patient outcomes. Our commitment to innovation, diversity, and collaboration drives us forward, making us an exciting place to work.Job DescriptionWe are seeking a highly organized Medical Device Program Coordinator...


  • Madrid, Madrid, España SGS A tiempo completo

    Job OverviewSentence fragment: SGS is seeking a Senior Lead Auditor – In-vitro diagnostic medical devices to support the expansion and development of the SGS IVDR certification service across our global network. This senior expert will be a key point of contact and mentor to colleagues, playing a key role in the qualification of new auditors.


  • Madrid, Madrid, España Abbott Laboratories A tiempo completo

    **About Abbott Laboratories**Abbott Laboratories is a global leader in healthcare, driven by innovation to improve people's lives. We're always looking towards the future, anticipating changes in medical science and technology.**Why Work at Abbott Laboratories?**At Abbott Laboratories, you can do meaningful work that matters, grow and learn, care for...