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- Tasks: Review MDSAP reports, ensure compliance, and provide technical approvals.
- Company: SGS is a global leader in testing, inspection, and certification, promoting sustainability and quality.
- Benefits: Enjoy flexible work schedules, continuous learning opportunities, and a supportive team culture.
- Why this job: Join a dynamic environment with a focus on teamwork and professional growth in the medical device sector.
- Qualifications: Requires a degree in relevant fields and four years of experience in medical devices.
- Other info: Opportunity to work in a multinational setting with diverse colleagues.
The predicted salary is between 36000 - 60000 £ per year.
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.
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 understanding 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.
MDSAP Technical Pack Reviewer employer: SGS
Contact Detail:
SGS Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land MDSAP Technical Pack Reviewer
✨Tip Number 1
Familiarise yourself with the MDSAP requirements and grading system. Understanding these intricacies will not only help you in interviews but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the medical device industry, especially those who have experience with MDSAP. Engaging in discussions can provide insights and potentially lead to referrals.
✨Tip Number 3
Stay updated on the latest regulatory changes and trends in medical devices. This knowledge will be crucial during interviews and will show that you are proactive and informed.
✨Tip Number 4
Prepare for potential technical questions by reviewing common MDSAP audit scenarios. Practising your responses can boost your confidence and help you articulate your expertise effectively.
We think you need these skills to ace MDSAP Technical Pack Reviewer
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly read the job description for the MDSAP Technical Pack Reviewer position. Understand the key responsibilities and qualifications required, as this will help you tailor your application.
Highlight Relevant Experience: In your CV and cover letter, emphasise your experience in medical devices and any relevant qualifications, such as your MDSAP Lead Auditor Qualification. Be specific about your previous roles and how they relate to the responsibilities outlined in the job description.
Demonstrate Communication Skills: Since good written English skills are essential for this role, ensure that your application is clear, concise, and free of errors. Use professional language and structure your documents logically to showcase your communication abilities.
Showcase Teamwork and Customer Focus: SGS values teamwork and customer focus. In your application, provide examples of how you've successfully worked in teams and met customer requirements in past roles. This will demonstrate that you align with the company's core values.
How to prepare for a job interview at SGS
✨Know Your MDSAP Inside Out
Make sure you have a solid understanding of the MDSAP requirements and grading system. Brush up on the latest regulations and standards, as well as the MDSAP Audit Approach manual. This knowledge will help you answer technical questions confidently.
✨Showcase Your Communication Skills
Since good communication is key in this role, be prepared to demonstrate your ability to convey complex information clearly. Practice explaining technical concepts in simple terms, as you may need to communicate with colleagues or clients who aren't familiar with medical device regulations.
✨Highlight Your Experience
Be ready to discuss your previous experience in medical devices, especially any roles related to MDSAP auditing or technical reviewing. Use specific examples to illustrate how you've successfully managed workloads, met KPIs, and contributed to team goals.
✨Emphasise Teamwork and Customer Focus
SGS values teamwork and customer satisfaction, so be sure to share examples of how you've worked collaboratively in the past. Discuss how you prioritise customer needs and ensure high-quality service delivery, as this aligns with the company's core principles.
