- Experience
- Any
- Salary
- —
- Openings
- 1
- Posted
- 2 days ago
- Work mode
- Work from home
- Eligibility
- Experienced professionals in the medical device certification field who have worked in a European notified body, preferably as a Lead Auditor or Product Assessor, and who are based in Europe with a valid work permit for their country of residence.
- Resume
- Required to apply
Job description
About SGS
SGS is a global leader in testing, inspection, and certification, widely regarded as a benchmark for sustainability, quality, and integrity. With a workforce of 99,600 people across 2,600 offices and laboratories, the company supports a safer, better-connected world through its international operations.
The organization promotes an open, international culture and provides a dynamic environment within a major global business. It places strong emphasis on professional standards, sustainability, and long-term employee development, with business principles centered on integrity, health, safety and environment, quality and professionalism, respect, sustainability, and leadership.
Role Overview
SGS is hiring a Final Reviewer & Certification Decision Maker to join its Global Medical Device team. This role reports to the team leader for Final Review and Certification Decision Making within the Medical Device function and carries global responsibility.
Main Purpose of the Role
The position is responsible for examining audit packs and associated documentation to confirm compliance with MDD 93/42 EC or MDR (EU) 2017/745 before deciding whether certification can be issued and whether any restrictions apply. The role also covers verification of QMS on-site audit records, technical documentation assessments, and evidence that the audited company meets the required regulatory standards and internal procedures.
You will check that major non-conformities and unresolved issues have been properly addressed and closed before the audit pack moves to certification decision. In addition, you will confirm that the final review was completed by an approved reviewer, that documentation is complete and satisfactory, and that any actions raised during review have been resolved. The role includes making the final determination on certificate issuance, as well as contributing to decisions involving concessions and certificate suspension when applicable.
You will work closely with auditors, product assessors, certificate decision makers, and the Global Medical Device Certification Manager, helping the team achieve operational goals and key performance indicators while ensuring certificates are delivered to customers in line with regulatory requirements.
Key Accountabilities
The Final Reviewer is expected to confirm that each audit pack shows the following:
- The audit has covered the requirements of the relevant standards and normative documents, including any extra accreditation requirements.
- The audit and all supporting documents were completed according to the correct procedures, including confirmation that the auditor or audit team had the appropriate competence.
- The audit team applied proper audit principles and practices, especially in relation to reporting findings and making decisions.
The Certification Decision Maker is expected to verify that the final technical review covers the following:
- Any scope of certification or accreditation matters tied to the applicable standards or normative documents.
- Completion of the technical review documentation.
- No unresolved issues remain open.
- Any audit-related concerns, including those connected to findings reporting and decision-making processes.
- Any matters relevant to the business or industry context in which the audit was conducted.
Additional responsibilities include understanding the business and industry context of the audit, evaluating the auditors’ interpretation and reporting of findings, supporting certificate decision makers, maintaining the company’s Code of Integrity & Professional Conduct, keeping professional knowledge current, ensuring compliance with professional, ethical, legal, and accreditation requirements, and reporting daily workload data along with any technical issues.
Work Arrangement
This is a remote role open to candidates located anywhere across Europe, provided they hold a valid work permit for their country of residence. Candidates are asked to submit their CV in English.
Additional Information
SGS highlights several reasons to join the company, including its stable position as a global market leader in the TIC industry, a flexible schedule with a hybrid-style working model, access to SGS University and Campus for continuous learning, a multinational workplace with colleagues from many regions, and access to a benefits platform. The company also promotes innovation, collaboration, continuous improvement, and an inclusive environment that supports professional and personal growth.
Qualifications
The company is seeking candidates with prior experience in a similar role within a European notified body, along with significant medical device experience as a Lead Auditor or Product Assessor in a Notified Body. Applicants should have a strong understanding of global medical device regulations, solid analytical ability to identify discrepancies or issues, good communication skills, strong team-building capability, and fluency in English. Knowledge of other languages is considered an advantage.