Temporary Contract Worksheet Approver (Maternity Cover)

We are seeking a dedicated Contract Worksheet (CWS) Approver for a maternity cover position. You will ensure compliance with Notified Body requirements for medical device certifications.

As a trusted reviewer of technical documentation, you will ensure regulatory adherence and maintain SGS’s commitment to excellence.

Key Responsibilities:

• Evaluate Certification Requests: Determine if third-party service product certification requests relate to medical devices and align with regulations.
• Document Review: Review and approve Medical Device Contract Worksheets and related documents to ensure MDR/IVDR compliance.
• Scope Validation: Verify certification requests fall within the Notified Body’s capabilities.
• Audit Team Allocation: Approve audit team competency assignments using predefined auditor codes.
• Regulatory Compliance: Adhere to Notified Body procedures and ensure accurate documentation.
• Decision-Making Support: Facilitate accurate acceptance/refusal of client projects.
• Ongoing Documentation Review: Assess pre-audit questionnaires, change requests, vigilance forms, and key documents.
• Client & Stakeholder Collaboration: Partner with affiliates for timely service to internal/external clients.
• Leadership Support: Assist the Global Medical Device Certification Manager.

Contract Details:

• Duration: Temporary, covering maternity leave.
• Training: Comprehensive onboarding and training on SGS policies and procedures.

Educational Background: Bachelor’s degree (or higher) in Engineering, Biomedical Sciences, or a related scientific discipline.

Industry Expertise: Proven experience working with medical devices and knowledge of regulatory frameworks and product standards.

Language Proficiency: Fluent in English; additional languages are beneficial.

Skills: Strong analytical skills, meticulous approach to document review, and ability to collaborate with cross-functional teams.

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