Qureos Mentor

Tata Elxsi

<div>
 
 Tata Elxsi is truly your home to a billion possibilities. We believe in opportunities for everyone to be bold and curious and seek to shape the future. Explore what&rsquo;s possible, discover what you love to do, and find accelerated paths for growth. At Tata Elxsi, you matter.
 
 
 
 
 
 Role- Labelling Specialist
 
 
 
 
 
 
 Job Description:
 
 
 
 The Label Designer for re-designing medical device labels as per brand standard guidelines for regulatory compliance. Label designer should be well-versed in Loftware Spectrum&reg; 4.6 version or 4.2 version. Provide creative solutions in medical device labelling and packaging design and validation.
 
 
 
 
 
 
 Title:
 
 Label Specialist
 
 
 
 Experience:
 
 5 - 15 years
 
 
 
 Domain:
 
 Medical Device
 
 
 
 Location:
 
 Pune
 
 
 
 
 
 
 Key Responsibilities:
 
 
 
 &bull; Develop and manage product labeling to ensure compliance with FDA, EU MDR, Health Canada, Global countries, UDI, and standards such as ISO 20417 and ISO 15223.
 
 
 &bull; Collaborate with cross-functional teams to develop label content and support the creation of Instructions for Use (IFU) and Operations Manuals.
 
 
 &bull; Create labelling input and specification documents.
 
 
 &bull; Lead and participate in design review meetings for label artwork, specifications, IFUs, and marketing collaterals.
 
 
 &bull; Develop and update labeling specifications, artwork files, and supporting documentation; coordinate translation requests.
 
 
 &bull; Review First Article Inspection (FAI) reports, verify final content, and support barcode grading and qualification.
 
 
 &bull; Provide support to resolve technical and operational labeling issues.
 
 
 &bull; Conduct design reviews for updated documents and complete Document Change Request (DCR) reviews in a timely and objective manner.
 
 
 &bull; Create and route Labeling Change order in PLM and ensure effective change management coordination using PLM tools such as Windchill and Agile.
 
 
 
 
 
 
 Required Skills &amp; Experience:
 
 
 
 
 
 
 &bull; Proven experience in medical device labeling and regulatory documentation.
 
 
 &bull; Proficiency in Loftware Cloud and Loftware Spectrum (hands-on or working knowledge).
 
 
 &bull; Strong command of Adobe Creative Suite (Illustrator, Photoshop, etc.).
 
 
 &bull; Hands-on or working knowledge of Windchill PLM and Agile PLM systems.
 
 
 &bull; In-depth understanding of global labeling requirements, including US, Canada, EU MDR, Australia, LATAM, and EMEA regions.
 
 
 &bull; Familiarity with regulatory standards such as IEC 60601, ISO 20417, and ISO 15223.
 
 
 &bull; Experience working in multidisciplinary teams.
 
 
 &bull; Excellent interpersonal, written, and oral communication skills.
 
 
 &bull; Strong organizational and project coordination abilities.
 
 
 &bull; High attention to detail and commitment to quality.
 
 
 
 
 
 
 Educational Qualification:
 
 
 
 &bull; Degree preferred, MTech / BE/ BTECH( Mechanical/Bio-medical/ Eq
 
 
 
 
 
 
 Good to have:
 
 
 <ul>
 <li>
 Experience in Adobe Illustrator, Adobe In-design, Adobe Photoshop, MS Office
 </li>
 </ul>
 
 
</div>

Labelling specialist

Join Tata Elxsi and explore 1   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Tata Elxsi

ABOUT_COMPANY

Labelling specialist