Final Reviewer & Certification Decision Maker Bucharest

Final Reviewer & Certification Decision Maker
Bucureşti
Bucharest, Bucharest, Romania

Job Description

We currently have an exciting opportunity at SGS for a Final Reviewer & Certification decision maker to join our highly successful Global Medical Device team.

In this role you will be reporting to the Final reviewer & Certification decision maker Medical Device Team leader and you will have a Global role.

Main Purpose of Role

• The role of the Final Reviewer & Certification decision maker is to review audit packs to verify data and their content for compliance with MDD 93/42 EC or MDR (EU) 2017/745 to take decision on reviewed audit packs to determine if the certificate shall be issued and if there is any applicable restrictions, after verifying data and their content for compliance with MDD 93/42 EC or MDR (EU) 2017/745.
• You will verify that audit documentation for QMS
  - site as well as technical documentation assessment is in compliance with the medical device regulations and internal procedures and allow a good understanding of the audit trail and support the relevant evidence of compliance of the audited company. You will verify that all major non conformity and any unsolved issue has been addressed and closed out before transferring the audit pack for certification decision.
• You will review whether the final review has been carried out by an approved Final Reviewer, ensuring that the final review documentation has been completed satisfactorily, confirms whether all/any actions raised by the Final Reviewer have been satisfactorily addressed and closed out and makes the final decision as to whether a certificate should be issued.
• You will be responsible for checking audit packs for QMS
  - site audit for MDD / MDR / ISO13485, for technical documentation assessment and any changes. The Certification Decision Maker takes decision related to audit pack for QMS
  - site audit for MDD / MDR / ISO13485, for technical documentation assessment and any changes, and is involved in concessions and certificate suspension when relevant.
• In this role you will be in close contact with the auditors, the product assessors, Certificate Decision makers and Global Medical Device Certification Manager and contributes in meeting operations objectives and Key Performance Indicators to deliver certificates to our customers and maintain regulatory compliance.

Key Accountabilities

• The Final Reviewer establishes whether the audit report pack demonstrates:
that the audit has addressed the requirements of the specific standards/normative documents; including any additional accreditation requirements specific to the standards
• that the audit has been carried out and associated documentation completed in accordance with relevant procedures; including verification that the auditor/audit team were confirmed as competent
• that the auditor/audit team members have applied principles and practices associated with undertaking audits; in particular those relating to reporting audit findings and
  - making processes.

• Experience in a similar position in a European notified body.
• Significant work experience in the medical device field as Lead Auditor or as Product Assessor in a Notified Body.
• Detailed understanding of global medical device Regulations and good analysis capacity to detect discrepancy or issues.
• Good communication skills.
• Strong team building skills.
• Fluent in English. Other languages are a benefit.

Please send you CV in English!

Why SGS?

• Join a globally recognized and stable company, a leader in the Testing, Inspection, and Certification (TIC) industry.
• Enjoy a flexible schedule and work model.
• Access SGS University and Campus for continuous learning options.
• Thrive in a multinational environment, collaborating with colleagues from multiple continents.
• Benefit from our comprehensive benefits platform.

Join Us: At SGS, we are dedicated to fostering an open, friendly, and supportive culture that thrives on teamwork. We value diversity and provide endless opportunities to learn, grow your expertise, and fulfill your potential.