Temporary Contract Worksheet (CWS) Approver

We are seeking a dedicated Contract Worksheet (CWS) Approver to join our technical team on a maternity cover basis.

In this temporary role, you will play a crucial part in ensuring compliance with Notified Body requirements for medical device certifications.

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

Key Responsibilities:

• Evaluate Certification Requests: Determine whether third-party service product certification requests pertain to medical devices and align with applicable regulatory frameworks.
• Document Review: Examine and approve Medical Device Contract Worksheets and related documents to ensure compliance with MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation).
• Scope Validation: Verify that certification requests are within the scope of our Notified Body’s capabilities.
• Audit Team Allocation: Approve audit team competency assignments using predefined auditor codes for required competencies.
• Regulatory Compliance: Ensure strict adherence to Notified Body procedures and accurate completion of all required documentation.
• Decision-Making Support: Facilitate prompt and accurate acceptance or refusal of client projects while safeguarding SGS’s integrity.
• Ongoing Documentation Review: Assess submitted pre-audit questionnaires, change requests, vigilance forms, and other key documents.
• Client and Stakeholder Collaboration: Partner with affiliates to deliver timely, responsive service to internal and external clients, prioritizing customer satisfaction.
• Leadership Support: Assist the Global Medical Device Certification Manager in effectively managing certification requests and associated processes.

Contract Details:

• Duration: Temporary role covering a maternity leave (specific dates to be discussed during the interview process).
• Training: Comprehensive onboarding and training on SGS policies and procedures to ensure a seamless transition.

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

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

Language Proficiency: Fluent in English; additional languages are an advantage.

Attention to Detail: Strong analytical skills and a meticulous approach to document review and regulatory compliance.

Teamwork and Communication: Ability to collaborate effectively with cross-functional teams while maintaining a client-focused mindset.

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