At a Glance
- Tasks: Conduct assessments on innovative medical devices and ensure compliance with regulations.
- Company: Join TÜV SÜD, a leader in safety and quality since 1866.
- Benefits: Enjoy flexible hours, competitive pay, and health management programs.
- Other info: Be part of a diverse team committed to innovation and integrity.
- Why this job: Make a real impact in healthcare by shaping the future of diagnostics.
- Qualifications: Degree in biomedical sciences and experience in Companion Diagnostics required.
The predicted salary is between 50000 - 65000 £ per year.
Innovationen bringen tiefgreifende Veränderungen mit sich und beeinflussen unser Leben in vielfältiger Weise. Bei der TÜV SÜD Gruppe sind wir in hohem Maße bestrebt, ein wichtiger Teil dieser Entwicklung und des Fortschritts zu sein. Wir sorgen für eine sichere und nachhaltige Zukunft und schaffen Vertrauen in neue Technologien. Wir beraten, wir prüfen, wir zertifizieren. Für die Sicherheit von Menschen und der Gesellschaft fordern wir uns jeden Tag aufs Neue heraus.
Tasks:
- Perform Technical Documentation Assessments (TDA) in accordance with IVDR requirements focused on Companion Diagnostics (CDx)
- Assess compliance of IVD devices against applicable IVDR provisions (e.g. Annex I, Annex IX, Annex X/XI)
- Review and evaluate: Performance evaluation (scientific validity, analytical and clinical performance), Benefit-risk assessment and risk management documentation, Post-Market Surveillance (PMS / PSUR) documentation, Instructions for Use (IFU) and Summary of Safety and Performance (SSP)
- Assess applicable IVDR regulatory requirements for Companion Diagnostics, including the consultation procedure involving the European Medicines Agency (EMA)
- Identify deficiencies and participate in iterative review cycles with manufacturers
- Prepare structured assessment reports in line with notified body processes
- Collaborate with cross-functional experts (e.g. clinical, QMS, software, AI) in multidisciplinary assessment teams
Qualification:
- University degree in: Medicine, pharmacy, engineering, biology, microbiology, chemistry, or other relevant biomedical sciences (or equivalent)
- Expertise in Companion Diagnostics, oncology, or biomarker-based testing is strongly required as well as experience in collaboration with European Medicines Agency (EMA) related to CDx products or drug approvals
- Four years of professional experience in the field of healthcare products or related activities such as: In vitro diagnostics (IVD), Regulatory affairs / compliance, Clinical/performance evaluation, Quality management or product development
- Two years of experience in the design, manufacture, testing or use of devices or technology of IVD products (e.g. in field of cancer, immunohistochemistry, genetic testing, next-generation sequencing, etc.)
- Solid understanding of IVDR (EU 2017/746) and relevant guidance documents
- Experience in reviewing or preparing technical documentation is a strong advantage
- Strong analytical skills and ability to assess complex scientific data
- Fluent in English (written and spoken)
- Structured and independent working style
- Very good MS Office skills
Was wir bieten:
- Flexible Arbeitszeiten: Unsere flexiblen Arbeitszeiten ermöglichen es Ihnen, Ihre Arbeitszeit an Ihre persönlichen Bedürfnisse anzupassen.
- Sonderzahlungen: Neben einem marktgerechten Gehalt bieten wir attraktive Sonderzahlungen wie z. B. eine Konzernerfolgsprämie oder andere leistungsorientierte Gehaltsbestandteile.
- Betriebliches Gesundheitsmanagement: Unser betriebliches Gesundheitsmanagement umfasst u.a. den E-Gym Wellpass, der Ihnen Zugang zu einer Vielzahl von Fitness- und Gesundheitsangeboten bietet, sowie eine betriebliche Altersvorsorge, die Ihnen hilft, für Ihre Zukunft vorzusorgen.
Bei der TÜV SÜD Gruppe arbeiten Menschen aus mehr als 100 Nationen zusammen. Unsere Stärke liegt in diesen zahlreichen und vielfältigen Perspektiven. Wir verpflichten uns, ein integrativer und vielfältiger Arbeitgeber zu sein, indem wir alle Menschen willkommen heißen. Vielfalt und Integration ist das Fundament unseres Unternehmens und wir fördern, ein Umfeld, in dem alle unsere Mitarbeitenden darauf vertrauen können, dass sie mit Respekt behandelt werden - unabhängig von Alter, Nationalität, ethnischem Hintergrund, Behinderung, Geschlecht und geschlechtlicher Identität oder sexueller Orientierung, Religion oder Weltanschauung.
Wir erwarten von unseren Mitarbeitenden, dass sie sich jederzeit gemäß des Ethikkodex der TÜV SÜD Gruppe und den Unternehmenswerten verhalten. Bewerbungen von Menschen mit Behinderung sind ausdrücklich erwünscht und werden bei ansonsten im Wesentlichen gleicher Eignung bevorzugt berücksichtigt.
Product Reviewer (IVD - Companion Diagnostics) (w/m/d) employer: TÜV SÜD AG
Die TÜV SÜD Gruppe ist ein hervorragender Arbeitgeber, der seinen Mitarbeitenden nicht nur flexible Arbeitszeiten und attraktive Sonderzahlungen bietet, sondern auch ein starkes Engagement für Gesundheit und Wohlbefinden durch umfassendes betriebliches Gesundheitsmanagement zeigt. Mit einer vielfältigen Belegschaft aus über 100 Nationen fördert das Unternehmen eine integrative Kultur, die auf Respekt und Zusammenarbeit basiert, und bietet zahlreiche Möglichkeiten zur beruflichen Weiterentwicklung in einem dynamischen Umfeld, das sich der Sicherheit und Qualität in der Medizintechnik widmet.
StudySmarter Expert Advice🤫
We think this is how you could land Product Reviewer (IVD - Companion Diagnostics) (w/m/d)
✨Tip Number 1
Network like a pro! Reach out to professionals in the IVD and Companion Diagnostics field on LinkedIn. Join relevant groups, participate in discussions, and don’t hesitate to ask for informational interviews. You never know who might have the inside scoop on job openings!
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of IVDR regulations and Companion Diagnostics. We recommend creating a cheat sheet of key points and questions you might face. This will help you feel more confident and ready to impress!
✨Tip Number 3
Showcase your expertise! When you get the chance to meet potential employers, bring along examples of your previous work or projects related to IVD. This not only demonstrates your skills but also shows your passion for the field.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we love seeing candidates who are proactive about their job search!
We think you need these skills to ace Product Reviewer (IVD - Companion Diagnostics) (w/m/d)
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter for the Product Reviewer role. Highlight your experience in Companion Diagnostics and any relevant projects you've worked on. We want to see how your background aligns with our mission at TÜV SÜD!
Showcase Your Expertise:Don’t hold back on showcasing your knowledge of IVDR and your analytical skills. Include specific examples of how you've assessed technical documentation or collaborated with regulatory bodies like the EMA. This will help us see your fit for the role!
Be Clear and Concise:When writing your application, keep it clear and to the point. Use bullet points where possible to make it easy for us to read. We appreciate a structured approach, just like you’d use in your assessment reports!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, you’ll find all the details about the position there!
How to prepare for a job interview at TÜV SÜD AG
✨Know Your IVDR Inside Out
Make sure you have a solid understanding of the In Vitro Diagnostic Regulation (IVDR) and its implications for Companion Diagnostics. Brush up on key provisions like Annex I, IX, and X/XI, as well as the consultation procedures with the European Medicines Agency (EMA). This knowledge will show your expertise and readiness to tackle the role.
✨Showcase Your Analytical Skills
Prepare to discuss your experience in assessing complex scientific data, especially in relation to performance evaluations and risk management documentation. Bring examples from your past work that highlight your analytical skills and how you've successfully navigated similar challenges in the healthcare products field.
✨Collaborate Like a Pro
Since the role involves working with cross-functional teams, be ready to talk about your collaborative experiences. Share specific instances where you worked with clinical, QMS, or software experts, and how those collaborations led to successful outcomes. This will demonstrate your ability to thrive in a multidisciplinary environment.
✨Prepare Structured Assessment Reports
Familiarise yourself with the process of preparing structured assessment reports in line with notified body processes. If you have examples of reports you've prepared or contributed to, be sure to mention them. This will illustrate your attention to detail and your understanding of regulatory requirements.
