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- Tasks: Review MDSAP reports and ensure compliance with regulations and standards.
- Company: SGS is the global leader in testing, inspection, and certification, promoting sustainability and quality.
- Benefits: Enjoy flexible work schedules, continuous learning opportunities, and a supportive corporate culture.
- Why this job: Be part of a dynamic team making a real impact in medical device safety and compliance.
- Qualifications: Requires a degree in relevant fields and MDSAP Lead Auditor qualification; experience in medical devices preferred.
- Other info: Join a diverse, multinational team dedicated to professional growth and integrity.
The predicted salary is between 36000 - 60000 £ per year.
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.
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.
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.
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 guidelines. Understanding the specific regulations and standards that SGS adheres to will not only help you in the interview 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 or attending relevant webinars can provide insights and potentially lead to referrals.
✨Tip Number 3
Prepare to discuss your previous experiences related to medical devices and auditing. Be ready to share specific examples of how you've handled compliance issues or improved processes in past roles.
✨Tip Number 4
Showcase your communication skills during the interview. Since the role requires good written English skills, practice articulating your thoughts clearly and concisely, as this will reflect your ability to generate reports and queries 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 accountabilities and required skills to tailor your application accordingly.
Highlight Relevant Experience: In your CV and cover letter, emphasise your four years of professional experience in the field of Medical Devices or related activities. If you have MDSAP Lead Auditor experience, make sure to showcase it prominently.
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 well.
Showcase Your Knowledge: Mention any relevant qualifications, such as your MDSAP Lead Auditor Qualification, and demonstrate your understanding of medical device knowledge and risk management systems in your application.
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. Familiarise yourself with the latest regulations, standards, and guidelines to demonstrate your expertise during the interview.
✨Showcase Your Communication Skills
Since good communication is key in this role, be prepared to discuss how you've effectively communicated technical information in the past. Use examples that highlight your ability to convey complex ideas clearly and concisely.
✨Prepare for Technical Questions
Expect questions related to medical device knowledge and risk management systems. Brush up on relevant codes and be ready to explain how you've applied your technical knowledge in previous roles.
✨Demonstrate Teamwork and Customer Focus
SGS values teamwork and customer satisfaction. Be ready to share examples of how you've worked collaboratively in a team setting and how you've prioritised customer needs in your previous experiences.
