Company Description
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 93,000 employees, SGS operates a network of over 2,400 offices and laboratories around the world.
Job Description
Working as a core member of our Medical Device technical team, you will review the technical Medical Device Worksheets submitted by our Sales team and associated documents to ensure that they meet our Notified Body requirements and expectations. You will be trained on SGS policies and procedures and assess the data submitted as first line information for Notified Body activities.
More specifically, you will:
- Establish whether the third party service product certification request concerns a Medical device;
- Review and approve Medical Device Contract Worksheets and associated documents to ensure they meet the regulatory requirements with MDR & IVDR;
- Evaluate the request and ascertain whether it matches our Notified Body’s scope;
- Approve allocation of audit team competency through use of predefined auditor codes for competences;
- Ensure that all Notified Body procedures have been complied with and the appropriate documentation completed satisfactorily;
- Enable delivery of client project acceptance or refusal promptly whilst maintaining the integrity of SGS;
- Review submitted pre audit questionnaire, change request, vigilance forms etc ..
- Partner with our affiliates to provide a rapid responsive service to both internal and external clients ensuring customer satisfaction as a high order of priority;
- Assist the Global Medical Device Certification Manager to effectively manage all applicable requests.
Qualifications
- Educated to degree level in Engineering, Sciences, Biomedical Sciences or a similar subject;
- Proven experience working with medical devices products;
- Fluent in English. Other languages are a plus.
Additional Information
We would like to hear from candidates based in Europe.
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