Job DescriptionWe 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.
Comprehensive training on SGS policies and procedures will be provided to set you up for success in this key role.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.QualificationsEducational 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