Medical Device UDI Labelling Independent Consultant
hace 2 semanas
Independent Contractor: Medical Device UDI Labelling Specialist
Overview
We are seeking a detail-oriented independent Medical Device UDI (Unique Device Identification) Labelling contractor to support our client organization in achieving compliance with global UDI requirements, including those mandated by the FDA, EU MDR/IVDR, and other international regulatory frameworks. This role focuses on the design, development, and implementation of UDI-compliant labelling solutions for medical devices.
Responsibilities
- Design and implement UDI labels for medical devices, ensuring compliance with global regulatory requirements.
- Collaborate with cross-functional teams to gather label content, including device identifiers, production information, and regulatory symbols.
- Ensure labels meet global standards such as GS1, HIBC, and ICCBBA specifications.
- Stay p-to-date on UDI regulations for all applicable regions, including FDA, EU MDR/IVDR, and other jurisdictions.
- Ensure all labeling solutions align with regulatory requirements and industry best practices.
- Conduct audits of existing labeling to identify and address non-compliance.
- Work with IT and quality teams to implement and maintain labeling systems, including enterprise resource planning (ERP) and labeling software.
- Test and validate label designs to ensure readability, durability, and compliance with scanning requirements.
- Create and maintain comprehensive documentation, including label specifications, templates, and approval records.
- Provide support for internal and external audits by maintaining accurate records of label-related activities.
- Train internal teams on UDI labeling processes, standards, and tools.
- Act as a subject matter expert for UDI-related queries and challenges.
- Identify and implement process enhancements to streamline UDI label development and compliance.
- Develop templates, guidelines, and standard operating procedures (SOPs) to ensure consistent labeling practices.
Qualifications
- Bachelors degree in regulatory affairs, engineering, life sciences, or a related field.
- Proven experience with UDI labeling for medical devices, including familiarity with global UDI requirements.
- Experience with regulatory submissions and device registration processes.
- Hands-on experience with labeling software such as BarTender, Loftware, or similar tools.
- Knowledge of global UDI standards (GS1, HIBC, ICCBBA).
- Proficiency in data management and ERP systems related to labeling.
- Strong understanding of barcoding and scanning technologies.
- Exceptional attention to detail and organizational skills.
- Strong communication and collaboration abilities, ability to consult with flexibility.
- Experience with EU EUDAMED UDI database submissions.
- Familiarity with ISO standards related to medical device labeling.
- Certification in regulatory affairs or medical device quality systems.
Contract
- Temporary contracts (project-based, potentially recurrent).
- Remote or on-site, based on project requirements.
- Competitive daily rate, commensurate with experience.
Summary
If you have expertise in medical device labeling and are passionate about ensuring global compliance, we encourage you to apply. Your skills will contribute directly to patient safety and regulatory adherence worldwide.
Consulting Role:
Independent consultants only (with registered business)
Business to business relationship
Expenses paid (pre-approved by client)
-
Medical Device Udi Labelling Independent Consultant
hace 4 semanas
Madrid, España Vision Achievement A tiempo completoIndependent Contractor: Medical Device UDI Labelling Specialist Overview We are seeking a detail-oriented independent Medical Device UDI (Unique Device Identification) Labelling contractor to support our client organization in achieving compliance with global UDI requirements, including those mandated by the FDA, EU MDR/IVDR, and other international...
-
Medical Device UDI Labeling Expert
hace 3 semanas
Madrid, Madrid, España Vision Achievement A tiempo completoJob 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...
-
Eudamed Technical Consultant
hace 1 semana
Madrid, España Vision Achievement A tiempo completo.EUDAMED Technical Specialist Consultant OverviewWe are seeking a highly skilled and detail-oriented EUDAMED Technical Specialist independent consultant to support our client's organizational compliance with the European Union's medical device regulations (MDR and IVDR).The consultant will play a pivotal role in ensuring accurate and efficient mass data...
-
Eudamed Technical Consultant
hace 4 semanas
Madrid, España Vision Achievement A tiempo completoEUDAMED Technical Specialist Consultant Overview We are seeking a highly skilled and detail-oriented EUDAMED Technical Specialist independent consultant to support our client's organizational compliance with the European Union's medical device regulations (MDR and IVDR).The consultant will play a pivotal role in ensuring accurate and efficient mass data...
-
EUDAMED Technical Consultant
hace 4 semanas
Madrid, España Vision Achievement A tiempo completoEUDAMED Technical Specialist Consultant Overview We are seeking a highly skilled and detail-oriented EUDAMED Technical Specialist independent consultant to support our client's organizational compliance with the European Union's medical device regulations (MDR and IVDR). The consultant will play a pivotal role in ensuring accurate and efficient mass data...
-
Scientific Inside Sales
hace 3 semanas
Madrid, España Eurofins Scientific A tiempo completoScientific Inside Sales - Medical Device Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins...
-
Medical Device Territory Sales Lead
hace 2 semanas
Madrid, Madrid, España Shockwave Medical, Inc. A tiempo completoJob 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...
-
Medical Device Expert
hace 3 semanas
Madrid, Madrid, España Sgs A tiempo completoJob 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...
-
Medical Device Specialist
hace 1 semana
Madrid, Madrid, España Sgs A tiempo completoJob 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...
-
Medical Device Evaluation Specialist
hace 1 semana
Madrid, Madrid, España Sgs A tiempo completoAbout SGS">SGS is a leading player in the conformity assessment process of medical devices, collaborating with clinicians and product reviewers to ensure compliance with EU MDR regulations.Your Role">As a Medical Device Evaluation Specialist, you will provide clinical oversight to guarantee that our clinical evaluation assessments meet the required...
-
Medical Device Assessor
hace 2 semanas
Madrid, Madrid, España Sgs A tiempo completoCompany 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...
-
Safety & Labelling Partner Lead
hace 3 semanas
Madrid, España Norgine A tiempo completo.At Norgine, our colleagues Dare themselves 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 you a fully-rounded experience with no limits.Bring everything about yourself that you're proud of, whether that's your passion for making a...
-
Safety & Labelling Partner Lead
hace 3 semanas
Madrid, España Norgine A tiempo completo.At Norgine, our colleagues Dare themselves 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 you a fully-rounded experience with no limits. Bring everything about yourself that you're proud of, whether that's your passion for making a...
-
Medical Device Sales Representative
hace 2 semanas
Madrid, Madrid, España Applied Medical A tiempo completoAre 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...
-
Safety & Labelling Partner Lead
hace 1 semana
Madrid, España Empresa Reconocida A tiempo completo.Want a 3D Career? Join Norgine. At Norgine, our colleagues Dare themselves 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 you a fully-rounded experience with no limits. Bring everything about yourself that you're proud of, whether...
-
Medical Device Product Lead
hace 3 días
Madrid, Madrid, España Barrington James A tiempo completoSenior Product Manager – Medical Device PlatformJoin a pioneering healthtech company revolutionizing personal healthcare by developing an innovative medical device platform integrated into a cutting-edge smartwatch, designed to monitor and analyze vital bodily functions such as heart rate, blood pressure, oxygen levels, and more.We are seeking an...
-
Safety & Labelling Partner Lead
hace 2 días
Madrid, España Empresa Reconocida A tiempo completo.Want a 3D Career?Join Norgine.At Norgine, our colleagues Dare themselves 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 you a fully-rounded experience with no limits.Bring everything about yourself that you're proud of, whether that's...
-
Safety & Labelling Partner Lead
hace 4 semanas
Madrid, España Norgine A tiempo completoAt Norgine, our colleagues Dare themselves 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 you a fully-rounded experience with no limits.Bring everything about yourself that you're proud of, whether that's your passion for making a...
-
Safety & Labelling Partner Lead
hace 3 semanas
Madrid, España Norgine A tiempo completoAt Norgine, our colleagues Dare themselves 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 you a fully-rounded experience with no limits.Bring everything about yourself that you're proud of, whether that's your passion for making a...
-
Safety & Labelling Partner Lead
hace 7 meses
Madrid, España Norgine A tiempo completoWant a 3D Career? Join Norgine. At Norgine, our colleagues Dare themselves 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 you a fully-rounded experience with no limits. Bring everything about yourself that you’re proud of, whether...