What are the responsibilities and job description for the MDSAP Technical Pack Reviewer position at SGS?
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 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.
At SGS, we have an open corporate and international culture. We offer a dynamic work environment in a leading global company. Our high professional standards and our sustainability approach guarantee you a future-oriented work environment. We invest in our employees for the long term and are committed to supporting your development within the company. Our business principles include: Integrity, Health, Safety & Environment, Quality & Professionalism, Respect, Sustainability, and Leadership.
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 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
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 KPI’s
- 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.
