Mdsap Technical Pack Reviewer

3 months ago

London, United Kingdom SGS Full time

Company Description

We are SGS - the world’s leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 98,000employees operate a network of 2,650 offices and laboratories, working together to enable a better, safer and more interconnected world.

**Job Description**:
**Main Purpose of Role**
- To conduct reviews of MDSAP reports and approve or raise queries based on technical and procedural knowledge
- Ensure that reviews are technically sound and in compliance with all applicable regulations, standards, guidelines and Competent Authority expectations
- Ensure that the highest level of service is provided through efficient service delivery and that customer requirements are met
- Ensure adherence to SGS Policies, procedures and processes
- As a member of the Global Medical Device office (MDO) to minimise risks associated with medical device certification.

**Key Accountabilities**
- Maintain up-to-date understanding of MDSAP requirement, including all jurisdiction requirements, regulatory transmittals, MDSAP Audit Approach manual, and all associated standards
- Maintain up-to-date understanding of the MDSAP grading system, corrective and preventive action, and use of the NGE form
- Review MDSAP audit packs according to specified requirements
- Generate Query Sheets for any noted deficiencies in the MDSAP audit pack
- Review and accept/reject query corrections
- Submit final approved documents to the Global MDSAP administrator for submission to REPS
- Submit final approved document to Applaudd and approve the MDSAP pack
- Approve MDSAP certificates after technical approval.
- Participate in team meetings
- Maintain on-time reviews based on Regulatory requirements
- Participate in achievement of KPIs
- Determine final approval for MDSAP audit packages and the issue of MDSAP certificates
- Signature authority for final MDSAP reports and NGE
- If approved as an AO submitter, make submissions to REPS as required
- Ensure full compliance with the Company’s Code of Integrity & Professional Conduct, and act in accordance with SGS UK’s Equality & Diversity Policy and ensure others do so.
- At all times, adopt a safe behaviour by exercising due regard for the health and safety of yourself, colleagues and clients, in line with the Company’s policies and procedures.

**Qualifications**:
**Experience & Qualifications**

Essential
- Four years professional experience in the field of healthcare products or related activities, such as in manufacturing, auditing or research, of which two years shall be in the design, manufacture, testing or use of the device or technology to be assessed or related to the scientific aspects to be assessed.
- Successful completion of a University or technical college degree or equivalent qualification in relevant studies e.g. medicine, pharmacy, engineering or other relevant sciences
- Lead Auditor Qualification
- At least 1yr experience of MDSAP auditing
- Medical device knowledge/codes
- Good communication techniques through electronic mediums
- Good written English skills (as reports will be reviewed/queried in English)

Desirable
- Experience of working to KPI’s
- Experience of planning own workload/priorities
- Ability to work with online systems
- Broad range of codes and previous Technical File review experience
- Experience as Medical Device audit Technical Reviewer

Additional Information

This position provides hybrid working environment.

The position will be hired based in UK/US/Canada.

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