MDSAP Technical Pack Reviewer

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 uptodate understanding of MDSAP requirement including all jurisdiction requirements regulatory transmittals MDSAP Audit Approach manual and all associated standards
• Maintain uptodate 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 ontime 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 Companys Code of Integrity & Professional Conduct and act in accordance with SGS UKs 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 Companys policies and procedures.

Qualifications :

Skills & Knowledge

Essential

• Medical device knowledge/codes
• Good communication techniques through electronic mediums
• Good written English skills (as reports will be reviewed/queried in English)  
• Thorough understand of risk management systems and requirements
• Customer Focus
• Teamwork

Desirable

• Experience of working to KPIs
• Experience of planning own workload/priorities
• Ability to work with online systems

Experience

Essential

• 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

Desirable

• Experience as Medical Device audit Technical Reviewer
• Previous experience working for regulatory jurisdictions or with regulatory requirements of any MDSAP Member country.

Qualifications

Essential

• 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

Desirable

• Advanced degrees in engineering science or other relevant areas

Additional Information :

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. 

Remote Work :

Yes

Employment Type :

Fulltime