| MDR Labelling Specialist Location Northridge, CA at Northridge, California, USA |
| Email: [email protected] |
| From: David Johnson, concord it systems [email protected] Reply to: [email protected] MDR Labelling Specialist Location Northridge, CA ONSITE POSITION Position Summary: The Labelling Specialist is primarily responsible for monitoring Labelling activities for the clients product in compliance with Europe Union Medical Device Regulation 2017/745. The Labelling Specialist supports TATA ELXSIs Labelling Domain to strengthen the existing capabilities, and competencies and develop new domain capabilities. Skills and Qualification: B. Tech / B.E / Science Degrees preferred (E.g.: Bio-Medical Engineering, Mechanical Engineering, Pharmaceutical). 3-6 years of experience in Regulatory Affairs preferably in the Medical Device industry. Experience in EU MDR and other Global regulations. Sound knowledge of international standards relative to QMS, Labelling, Packaging, and Sterilization such as ISO-13485, ISO-14971, ISO-15223, ISO-11607, and ISO-11135 is preferred. Proficient in Labelling Design, Design Verification, Shelf life, Test method validation, Material Validation, and Process validation. Good understanding of the Raw Materials used for manufacturing medical devices. Good understanding of medical terminologies, and human anatomy. Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types under general supervision. Ability to understand the functionality/intended use of complex devices. Ability to work across various domains - planning & prioritizing, tracking monthly matrices, and creating dashboards. Proficiency in Microsoft Office Suite (Word, Excel, Teams, and PowerPoint). Strong attention to detail, ability to multi-task, and deliver on deadline. Able to maintain up-to-date knowledge in the area of practice. Ability to apply effective interpersonal, verbal, and written communication skills. Ability to work independently and in a multi-cultural team environment. Knowledge of labelling Bio-compatibility of Sterile Barrier System. Sound knowledge in Technical document compilation and notified body submission. Ability to lead the project with respect to project tracking and management Ability to perform an expert review on labelling deliverables. Role and Responsibilities: Responsible for the creation of documents as per EU MDR regulations Development and review of various required labelling components, including component specifications, template designs and final label image specifications. Review, manage and monitor timelines of labelling projects and ensuring all deadlines are met. Review, and release labelling artworks for package labels, cartons and other related materials ensuring that they meet all documented design inputs via PLM tool. Comprehend labelling system requirements and review designing templates, troubleshooting the functionality of existing templates Identification and implementation of potential improvements to the labelling development processes, systems, tools and/or policies. Coordination and proof read the translations of labelling content before sharing with all the stakeholders Authoring/updating various labelling/regulatory documents for medical devices that include a Technical Document summary. Compliance with the client and internal Standard Operating Procedures, Work Instructions and guidelines. Facilitate in Audits and Inspections as required. Should assist the Team Manager/Program manager to ensure scheduled delivery. Must have prior understanding of various labelling systems in a regulated industry Experienced in working with Adobe Illustrator and/or other graphic designing tools Responsible to deliver any additional tasks/duties as assigned by the manager Strong problem solving/ troubleshooting skills related to systems Configuration of new printer and updating existing printer setups in the facility Thanks & Regards David Johnson Sr.IT Recruiter Desk Number: +1 209 706 0814 Concord Id :[email protected] Concord IT Systems, Inc - Project & Staffing Solutions (https://concorditsystems.com) Keywords: information technology California Idaho |
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| Tue Aug 01 18:47:00 UTC 2023 |