Senior Medical Device Certification Specialist
Há 6 dias
Overview
">We are seeking a dedicated professional to join our technical team as a Senior Medical Device Certification Specialist on a maternity cover basis.
">About the Role
">In this temporary position, you will play a crucial part in ensuring compliance with Notified Body requirements for medical device certifications.
">You will be responsible for reviewing and approving technical documentation submitted by our Sales team, ensuring regulatory adherence and maintaining SGS's commitment to excellence.
">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.
Qualifications and Requirements
">To succeed in this role, you will need:
">- Bachelor's degree (or higher) in Engineering, Biomedical Sciences, or a related scientific discipline.
- Proven experience working with medical devices, with knowledge of regulatory frameworks and product standards.
- Fluent in English; additional languages are an advantage.
- Strong analytical skills and a meticulous approach to document review and regulatory compliance.
- Ability to collaborate effectively with cross-functional teams while maintaining a client-focused mindset.
Salary
">The estimated annual salary for this position is $85,000 - $110,000, depending on location and experience.
">About SGS
">SGS is a global leader in the TIC industry, offering flexible scheduling and remote work options. We prioritize diversity and provide opportunities for continuous learning and growth.
">How to Apply
">If you're a motivated and dynamic professional looking to make a meaningful impact, apply now to join our team at SGS.
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