Capgemini Engineering
Website:
capgemini.com
Company:
https://www.linkedin.com/company/capgemini-engineering
Industries: Information Services
Job details:
Labelling Specialist | 4 To 6 years | Bangalore
Basic Qualifications:
- BE/ B.Tech or equivalent Degree in a technical discipline.
- 5+ years plus professional experience in the Labeling Content development and Graphic Design preferably in medical device or pharmaceutical industry.
- Strong knowledge of Regulatory and Labeling standards for Medical Device/Pharmaceutical industry.
Roles & Responsibilities:
1) Experience in technical documentation for medical devices
2) Hands‑on experience in authoring labels, IFUs, and literature for medical devices
3) Experience in Design History File (DHF) remediation
4) Knowledge of creating objects, book maps, DITAVAL files, and baselines using Arbortext Editor
5) Experience in Failure Modes and Effects Analysis (FMEA) with specific focus on Labeling and IFU
6) Knowledge of risk management activities related to medical devices
7) Strong understanding of applicable regulatory standards for medical devices and labeling: ISO 15223‑1, IEC 82079, IEC 60601‑1, ISO 14971, EU MDR 2017/745
8) Hands‑on experience with tools such as: Arbortext Editor, Windchill, Adobe InDesign, Adobe Illustrator, Beyond Compare, Harmonizer, Adobe Reader
Mandatory Skills:
1) Hands‑on experience in authoring labels, IFUs, and literature for medical devices
2) Knowledge of creating objects, book maps, DITAVAL files, and baselines using Arbortext Editor
3) Strong understanding of applicable regulatory standards for medical devices and labeling: ISO 15223‑1, IEC 82079, IEC 60601‑1, ISO 14971, EU MDR 2017/745
4) Hands‑on experience with tools such as: Arbortext Editor, Windchill, Adobe InDesign, Beyond Compare, Harmonizer, Adobe Reader
Click on Apply to know more.