SGS
Final Reviewer & Certification Decision Maker
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Final Reviewer & Certification Decision Maker
Final Reviewer & Certification Decision Maker – Medical Device (Remote – Europe-based)
About SGS
We are SGS—the world’s leading testing, inspection, and certification company. Recognized as the global benchmark for sustainability, quality, and integrity, we employ 99,600 professionals across 2,600 offices and laboratories, enabling a safer, more interconnected world.
At SGS, we foster an open corporate and international culture with a dynamic work environment. Our commitment to integrity, quality, sustainability, and leadership ensures a future-oriented and rewarding career. Benefits include:
- Long-term employee development
- Professional growth opportunities
- A flexible hybrid model
Role Overview
We are seeking a global, remote Final Reviewer & Certification Decision Maker to join our highly successful Global Medical Device team.
Main Purpose
The role focuses on reviewing and deciding certification for medical device compliance, specifically assessing:
- Audit packs against MDD 93/42/EC and MDR (EU) 2017/745
- Technical documentation assessment
- QMS on-site audit compliance
Key Responsibilities
- Review and verify audit packs, ensuring:
- Compliance with MDD/MDR requirements
- Correct resolution of major non-conformities and outstanding issues
- Alignment with internal procedures and regulatory standards
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Validate final review documentation by an approved reviewer:
- Confirm that all raised actions have been resolved
- Approve or reject certificate issuance based on compliance
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Oversee QMS audits (MDD/MDR/ISO 13485) and technical documentation reviews, contributing to concessions or certificate suspensions when needed
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Collaborate with:
- Auditors & Product Assessors
- Certificate Decision Makers & Global Medical Device Certification Manager
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Drive operational objectives and KPIs to meet customer demands while ensuring regulatory compliance
Core Accountabilities
As Final Reviewer
- Assess if audit packs meet:
- Specific standards/norm requirements
- Accreditation criteria (if applicable)
- Competence verification for auditors/audit teams
- Audit principles & reporting accuracy
As Certification Decision Maker
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Validate if the final technical review addresses:
- Scope scalability issues
- All unresolved findings
- Industry-specific compliance concerns
- Ingenuity and auditors' interpretations”
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Support senior decision-makers, ensuring ethical compliance with SGS’ Code of Integrity & Professional Conduct
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Continuously update professional expertise to align with sector standards
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Ensure adherence to legal, ethical, and accreditation requirements
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Provide daily workload updates and technical consultation
Requirements
Minimum Qualifications
✔ Experience in similar role within a European notified body (essential) ✔ Proficiency in medical devices as a Lead Auditor or Product Assessor in a Notified Body (essential) ✔ Strong understanding of global medical device regulations (MDD/MDR) and analytical assessment skills ✔ Excellent written & verbal communication in English ✔ Ability to work in a team environment and build collaboration
✔ (Desirable) Proficiency in additional languages
Why SGS?
🌍 Global leader in Testing, Inspection & Certification (TIC) ✅ Flexible hybrid and remote work model 🎓 SGS University for continuous industry savoir faire acquittance 🌐 Multinational team with a varied cultural dynamic 💼 Notable benefits platform 🌱 Supportive work culture
Committed to diverse & inclusive growth
Apply for this position by sending your CV in English!
(Note: candidates must hold a valid work permit for their country of residency.)
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