At a Glance
- Tasks: Conduct assessments on Companion Diagnostics to ensure compliance with IVDR requirements.
- Company: Join TÜV SÜD, a leader in medical technology and healthcare.
- Benefits: Enjoy flexible working hours, competitive salary, and health management programs.
- Other info: Work in a diverse, inclusive environment with excellent career growth opportunities.
- Why this job: Make a real difference in healthcare by evaluating innovative diagnostic products.
- Qualifications: Degree in relevant biomedical sciences and expertise in Companion Diagnostics required.
The predicted salary is between 50000 - 65000 £ per year.
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
Additionally
- Fluent in English (written and spoken)
- Structured and independent working style
- Very good MS Office skills
We offer flexible working hours, attractive bonuses, and a comprehensive health management programme. We are committed to being an inclusive and diverse employer.
Product Reviewer (IVD - Companion Diagnostics) (w/m/d) employer: TÜV SÜD
TÜV SÜD is an exceptional employer that prioritises employee well-being and professional growth, offering flexible working hours and a comprehensive benefits package including performance bonuses and health management programmes. With a strong commitment to diversity and inclusion, the company fosters a respectful and supportive work environment, making it an ideal place for professionals in the healthcare and medical technology sectors to thrive and contribute meaningfully to innovative projects in locations like Munich and London.
StudySmarter Expert Advice🤫
We think this is how you could land Product Reviewer (IVD - Companion Diagnostics) (w/m/d)
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like TÜV SÜD. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like TÜV SÜD.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like TÜV SÜD. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what TÜV SÜD is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Product Reviewer (IVD - Companion Diagnostics) (w/m/d)
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at TÜV SÜD!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show TÜV SÜD that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at TÜV SÜD!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At TÜV SÜD, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at TÜV SÜD
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at TÜV SÜD that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with TÜV SÜD’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
