Medical Device Certification Specialist
Há 5 dias
We are seeking a dedicated Medical Device Certification Specialist to join our team on a maternity cover basis.
About the RoleIn this temporary position, 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.
Main 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.
- 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.
$60,000 - $80,000 per annum.
Contract DetailsThis is a temporary role covering a maternity leave. Comprehensive onboarding and training on SGS policies and procedures will be provided to ensure a seamless transition.
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