Design Assurance Specialist - MDR/ISO 14971 (Contract)

Real; Munster; On-site; EUR 83,000 - 129,000; Part time

Job summary

Real is seeking two experienced Design Assurance Contractors to support growing programme activity across R&D, Quality and Regulatory in Munster, Ireland. You will contribute to design controls, MDR Technical File remediation, risk management and the creation, review and approval of compliant design documentation for new product development, design changes and design transfer.

Ideal candidates have hands-on Design Assurance and Design Controls experience, ISO 14971 risk management, and

Qualifications

• Experience with Design Assurance and Design Controls
• MDR Technical File remediation experience
• ISO 14971 Risk Management
• DHF, Technical File and risk documentation
• Design Verification and Validation support

Responsibilities

• Support medical device programmes across new product development, design changes and design transfer.
• Contribute to Design Controls, MDR Technical File remediation, and risk management activities; create, review and approve compliant design documentation.

Skills

Design Assurance

Design Controls

MDR File Remediation

Risk Management

Documentation

Verification & Validation

Job description

Real is seeking two experienced Design Assurance Contractors to support growing programme activity across R&D, Quality and Regulatory in Munster, Ireland. You will contribute to design controls, MDR Technical File remediation, risk management and the creation, review and approval of compliant design documentation for new product development, design changes and design transfer.

Ideal candidates have hands-on Design Assurance and Design Controls experience, ISO 14971 risk management, and