Medical Device UDI Labelling Independent Consultant
4 weeks ago
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.
-
Mumbai, India Vision Achievement Full timeIndependent 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...
-
Senior Medical Device UDI Labeling Specialist
2 weeks ago
Mumbai, Maharashtra, India Vision Achievement Full timeJob OverviewVision Achievement is seeking a detail-oriented Medical Device UDI Labelling Specialist to support our client organization in achieving compliance with global UDI requirements.ResponsibilitiesDesign and implement UDI labels for medical devices, ensuring compliance with global regulatory requirements.Collaborate with cross-functional teams to...
-
Medical Device UDI Compliance Expert
5 days ago
Mumbai, Maharashtra, India Vision Achievement Full timeJob DescriptionWe are seeking a detail-oriented Medical Device UDI Labelling Specialist to support our client organization in achieving compliance with global UDI requirements. This role focuses on the design, development, and implementation of UDI-compliant labelling solutions for medical devices.About Vision AchievementVision Achievement is a leading...
-
Medical Device Labeling Compliance Expert
3 weeks ago
Mumbai, Maharashtra, India Vision Achievement Full timeWe are seeking a detail-oriented expert to support our client organization in achieving compliance with global medical device labeling requirements.As a Medical Device Labeling Compliance Expert, you will focus on the design, development, and implementation of labeling solutions for medical devices that meet global regulatory standards. Your responsibilities...
-
HR Generalist
4 weeks ago
Mumbai, Maharashtra, India OMC Medical Limited Full timeCompany OverviewOMC Medical Limited is a UK-based healthcare company specializing in medical device regulations, Brexit customs clearance, and EUDAMED registration. We provide comprehensive solutions to the healthcare industry.SalaryThe estimated salary for this role is £30,000 - £40,000 per annum, depending on experience.Job DescriptionThis is a full-time...
-
Medical Device Sales Expert
1 month ago
Mumbai, Maharashtra, India Nand Imperial Consulting Full timeAbout the RoleWe are seeking an accomplished Medical Device Sales Expert to join our team at Nand Imperial Consulting.The successful candidate will be responsible for promoting and selling a range of medical devices, including Litecure Laser, Frequencer, Gamma Camera, Mobile X-Ray Products, and Virtual Reality Surgery Simulator.
-
Medical Device Sales Executive
1 month ago
Mumbai, India DNV Full timeThe Sales Executive -Medical Devices Sectorcultivates new business opportunities and develops long-term business partnerships with clients related to medical devices. Assesses customer needs, creates solutions based on the DNV product portfolio, including training and certification, EU requirements, US/MDSAP, ISO standards, and other complimentary schemes....
-
Medical Sales Executive
2 months ago
Mumbai, Maharashtra, India Unity Derma Medical Pvt. Ltd. Full timeDiploma / Bachelor in Biomedical/Electronics engineering - BCA /B.Com /BBA/B.Sc. any Graduates with relevant related experience will also be considered - experience of Pharma & Medical device sales, marketing in relevant business is preferred. - Travel within the allocated areas. - Two-wheeler with valid driving license is necessary. - willing to travel...
-
Regulatory Affairs Director for Medical Devices
1 month ago
Mumbai, Maharashtra, India G&L Healthcare Advisors Full timeWe are seeking a highly skilled Regulatory Affairs professional to lead our medical device regulatory strategy and submission processes.Job OverviewG&L Healthcare Advisors is a leading consulting firm in the medical device industry, providing expert guidance and support to clients worldwide.Estimated Salary: $120,000 - $180,000 per yearAbout the RoleThis...
-
Medical device sales executive
1 month ago
Mumbai, India DNV Full timeThe Sales Executive -Medical Devices Sector cultivates new business opportunities and develops long-term business partnerships with clients related to medical devices. Assesses customer needs, creates solutions based on the DNV product portfolio, including training and certification, EU requirements, US/MDSAP, ISO standards, and other complimentary...
-
Medical Device Sales Executive
1 month ago
mumbai, India DNV Full timeThe Sales Executive -Medical Devices Sector cultivates new business opportunities and develops long-term business partnerships with clients related to medical devices. Assesses customer needs, creates solutions based on the DNV product portfolio, including training and certification, EU requirements, US/MDSAP, ISO standards, and other complimentary schemes....
-
Medical Device Sales Executive
1 month ago
Mumbai, India DNV Full timeThe Sales Executive -Medical Devices Sector cultivates new business opportunities and develops long-term business partnerships with clients related to medical devices. Assesses customer needs, creates solutions based on the DNV product portfolio, including training and certification, EU requirements, US/MDSAP, ISO standards, and other complimentary schemes....
-
Medical Device Sales Executive
1 month ago
Mumbai, India DNV Full timeThe Sales Executive -Medical Devices Sector cultivates new business opportunities and develops long-term business partnerships with clients related to medical devices. Assesses customer needs, creates solutions based on the DNV product portfolio, including training and certification, EU requirements, US/MDSAP, ISO standards, and other complimentary schemes....
-
Medical Device Sales Executive
1 month ago
Mumbai, India DNV Full timeThe Sales Executive -Medical Devices Sector cultivates new business opportunities and develops long-term business partnerships with clients related to medical devices. Assesses customer needs, creates solutions based on the DNV product portfolio, including training and certification, EU requirements, US/MDSAP, ISO standards, and other complimentary schemes....
-
Medical Device Recruiter
3 weeks ago
Mumbai, Maharashtra, India Meril Full timeAbout the RoleWe are seeking a highly skilled Medical Device Recruiter to join our Human Resources department at Meril Life Sciences, a global leader in medical device manufacturing. The ideal candidate will oversee full-cycle recruiting for our sales division on a global scale, developing long-term strategies, building talent pipelines, and fostering...
-
Position Title: Medical Device Maintenance Work
7 months ago
Mumbai, Maharashtra, India Qrata Full time**Position Title: Medical Device Maintenance Work Executive** **Job Summary**: The Medical Device Maintenance Work Executive is responsible for overseeing the maintenance and repair of medical devices within a healthcare facility or medical device manufacturing company. This role involves ensuring that medical equipment is properly maintained, calibrated,...
-
Mumbai, Maharashtra, India Capgemini Engineering Full timeJob DescriptionWe are seeking a highly skilled Senior Software Engineer to join our team at Capgemini Engineering. As a key member of our development team, you will be responsible for designing, developing, and maintaining complex software applications for medical devices.Key Responsibilities:Develop full life cycle application software for medical devices...
-
Medical Device Biocompatibility Specialist
3 days ago
Navi Mumbai, Maharashtra, India IF MedTech Pvt Ltd Full timeRevolutionize Healthcare with IF MedTech Pvt LtdWe are seeking a highly skilled Medical Device Biocompatibility Specialist to join our team at IF MedTech Pvt Ltd in Navi Mumbai. This role is dedicated to ensuring the safety and efficacy of our medical devices through cutting-edge design, development, and pilot manufacturing.About the RoleThe successful...
-
Medical Device Sales Specialist
3 weeks ago
Mumbai, Maharashtra, India DNV Full timeAbout the Role: We are seeking a highly motivated and results-driven Sales Executive to join our team at DNV. The successful candidate will be responsible for cultivating new business opportunities and developing long-term partnerships with clients in the medical devices sector.Job Description:Sales Strategy: Develop and execute a sales strategy that targets...
-
Executive Regulatory Affairs Labelling
4 weeks ago
Mumbai, Maharashtra, India Piramal Pharma Solutions Full timeBusiness: Piramal Critical Care Department: Regulatory Affairs Location: Kurla, Mumbai Travel: Low **Job Overview**: Responsible for all artworks and labeling components of Piramal Critical Care Products Worldwide with adherence to the labeling processes, ensuring compliance with innovator labeling, internal & external partners, and GMP standards and...