Medical Device Auditor

Sofomation Energy; India; On-site; INR 1,500,000 - 2,400,000; Full time

Job summary

Sofomation Energy seeks an experienced Medical Devices-Assessor/Auditor to join its regulatory affairs team. The candidate will evaluate conformance to ISO 13485, MDD, MDR and related Indian regulations, lead risk assessments, and work with a cross-functional team.

You should have about 10 years in healthcare products and at least 5 years in quality management, with strong knowledge of sterilization and non-active devices.

Qualifications

• 10+ years in healthcare products or related activities.
• 5+ years in quality management is essential.

Responsibilities

• Collaborate with a team of assessors/auditors.

Skills

Quality management

Regulatory affairs

Healthcare industry knowledge

Tools

ISO 13485

MDD 93/42/EEC

MDR 2017/745

MDSAP

IMDR

EN ISO 14971 risk management

Job description

Position: Medical Devices-Assessor/ Auditor

Experience

• Require about 10 years of professional experience in relevant field of healthcare products or related activities e.g.: work in medical devices industry such as research and development, manufacturing, quality management, regulatory affairs.
• 5 + years relevant professional experience in quality management is essential.

Minimum Requirement

• Good knowledge of ISO 13485, MDD 93/42/EEC/ Indian Medical Device Regulations and their application & Knowledge of MDR 2017/745, MDSAP, IMDR
• Experience with Risk Management EN ISO 14971
• Solid knowledge of non-active devices & Solid knowledge of sterilization processes
• Work actively with a Team of Assessors/ Auditors.