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MDSAP Technical Pack Reviewer
@SGS
[Hiring] MDSAP Technical Pack Reviewer @SGS
Mar 31, 2025 - SGS is hiring a remote MDSAP Technical Pack Reviewer. 💸 Salary: unspecified. 📍Location: UK.
This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more.
Role Description
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 the SGS system 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
- Medical device knowledge/codes.
- Good communication techniques through electronic mediums.
- Good written English skills (as reports will be reviewed/queried in English).
- Thorough understanding of risk management systems and requirements.
- Customer Focus.
- Teamwork.
Experience
- Four years professional experience in the field of Medical Devices or related activities (Advanced degrees can substitute for a maximum of three years of working experience).
- In exceptional cases, a demonstration of equivalent knowledge and skills may be acceptable.
- Previous MDSAP Lead Auditor Experience.
Qualifications
- Successful completion of a university or technical college degree or equivalent qualification in relevant studies e.g. medicine, science, pharmacy, engineering or other relevant sciences.
- MDSAP Lead Auditor Qualification.
Benefits
- 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.
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| 📍 | Be aware of the location restriction for this remote position: UK |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
Back to Remote jobs >
QA
QA
|
Salary
💸
unspecified
|
Remote
Location
UK
|
|
Job Type
full-time
|
Posted
Mar 31, 2025
|
️
| 📍 | Be aware of the location restriction for this remote position: UK |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
