System Engineer – EU MDR 2017/745- Domain-Medical

TeamPlus Staffing Solution Pvt Ltd; Pune District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

TeamPlus Staffing Solution Pvt Ltd seeks a Systems Engineer with 5–12 years of experience to support EU MDR remediation programs for medical devices (Class I–III). The role involves gap assessment, design control remediation, requirements engineering, traceability, risk management, documentation updates, and cross-functional collaboration to ensure compliance with EU MDR and applicable standards.

The position emphasizes regulatory expertise, cross-functional teamwork, and attention to detail to

Qualifications

• 5–12 years of experience in medical device regulatory compliance.
• Experience with EU MDR remediation programs (Class I-III).
• Strong knowledge of ISO 13485 and ISO 14971.

Responsibilities

• Perform gap assessments for MDR remediations.
• Lead design control remediation activities.
• Conduct requirements engineering and maintain traceability.
• Manage risk and update technical documentation.
• Collaborate cross-functionally to ensure compliance.

Skills

Regulatory compliance

Risk management

Requirements engineering

Job description

Years of Experience: 5-12 Years

The Systems Engineer will support EU MDR 2017/745 remediation
programs for Class I, II and III medical devices. The role involves gap
assessment, design control remediation, requirements engineering,
traceability management, risk management, technical documentation
updates, and cross-functional collaboration to ensure compliance with
EU , MDR, ISO 13485, ISO 14971 and applicable product standards.