Post Market Surveillance (PMS) role

L&T Technology Services (LTTS) is looking for candidates in PMS role in Mysuru location.

Hands on experience working on Medical Device Regulations (MDR) 2017/745

4-8 years of experience in Post Market Surveillance (PMS)

Requirements for Post-Market Surveillance

• Technical documentation for post-market surveillance system as per Annex-3
• Person Responsible for Regulatory Requirements according to Article 15
• PMS Systems for the Manufacturers according to Article 83
• E2E Drafting of Post-market surveillance plan (PMSP) According to Article 84
• E2E Drafting of Periodic safety update report (PSUR) According to Article 86
• Medical devices Quality management systems as per ISO 13485:2016
• Medical devices Application of risk management to medical devices as per ISO 14971:2019
• Medical devices post-market surveillance for manufacturers as per ISO/TR 20416:2020