IT - Risk Management

The team developing industry leading X-ray generation subsystems is looking for highly motivated regulatory engineers to join them in ensuring compliance and availability of these subsystems for CT scanners to all the global markets of interest.

Regulatory Engineer will be working on compliance activities for various medical devices global regulations.

Responsibilities

• Collaborate with cross functional teams (engineering, manufacturing, regulatory, sourcing, etc.) to lead or support compliance activities to medical device regulations.
• Review regulatory compliance change notifications and drive associated actions to be compliant by the effective date
• Lead compliance efforts to various global regulations (E.g. REACH, ROHS, etc.) in alignment with the quality management system
• Lead or support product regulatory documentation updates (e.g. NRTL reports, tech file, etc.)
• Support regulatory audits and inspections to ensure post-market surveillance compliance.

Qualifications we seek in you!

Minimum Qualifications

Preferred Qualifications / Skills

Skills Required

Iso 13485, Team Development, it risk management , Qms, Regulatory Compliance