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- Tasks: Lead R&D projects for PCR-based diagnostic tests from research to regulatory approval.
- Company: Join a top player in the molecular diagnostics field, making a real impact.
- Benefits: Enjoy competitive pay, flexible working options, and a collaborative team environment.
- Why this job: Be part of innovative projects that shape healthcare and improve lives.
- Qualifications: Advanced degree in Molecular Biology or related field; experience in IVD project management required.
- Other info: Fluency in German and English is essential; project management certification is a plus.
The predicted salary is between 36000 - 60000 £ per year.
We are excited to present a rewarding opportunity for an experienced R&D Project Manager to join a leading organization in the molecular diagnostics sector. This role is critical in managing the development of PCR-based IVD tests, overseeing projects from conception to regulatory approval, and ensuring alignment with industry standards.
Key Responsibilities:
- Lead and manage development projects for molecular diagnostic PCR-based tests, ensuring timely execution from initial research to regulatory approval.
- Plan and oversee analytical and clinical performance evaluations, ensuring compliance with IVDR and other regulatory requirements.
- Coordinate method development, experimental design, and optimization of molecular diagnostic assays for point-of-care and point-of-need applications.
- Drive cross-functional collaboration, working closely with R&D, regulatory affairs, manufacturing, and commercial teams to align project objectives.
- Manage project timelines, budgets, and resource allocation, ensuring efficient progress and risk mitigation.
- Oversee documentation and reporting in compliance with regulatory standards and internal quality requirements.
Ideal Candidate:
- Educational Background: Advanced degree (MSc/PhD) in Molecular Biology, Biotechnology, Bioengineering, or a related field.
- Experience: Proven track record in managing R&D projects within the in-vitro diagnostics (IVD) or medical device sector, ideally in a regulated environment.
- Technical Expertise: Strong knowledge of RNA/DNA extraction & purification methods, molecular diagnostics, and PCR-based assay development.
- Project Management Skills: Ability to independently plan, execute, and oversee complex R&D projects, ensuring seamless coordination between teams.
- Regulatory & Compliance: Understanding of IVDR regulations, technical documentation, and validation processes for IVD products.
- Communication & Leadership: Excellent stakeholder management skills, with fluency in German and English.
Plus Points:
- Experience in the approval process of IVD medical devices and preparation of technical documentation.
- Knowledge of microfluidics applications in diagnostics.
- Expertise in primer and probe design and multiplex PCR assay development.
- Certification in Project Management (PMP, PRINCE2, or equivalent).
If this sounds like something you would be interested in, I would love to receive your application directly or feel free to reach out via email.
R&D Project Manager - IVD employer: Barrington James
Contact Detail:
Barrington James Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land R&D Project Manager - IVD
✨Tip Number 1
Network with professionals in the molecular diagnostics field. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends, which can give you an edge in interviews.
✨Tip Number 2
Familiarise yourself with the latest IVDR regulations and compliance standards. Being well-versed in these areas will not only boost your confidence but also demonstrate your commitment to the role during discussions.
✨Tip Number 3
Prepare to discuss specific projects you've managed that align with PCR-based IVD tests. Highlight your experience in cross-functional collaboration and how you successfully navigated challenges in previous roles.
✨Tip Number 4
Brush up on your technical knowledge regarding RNA/DNA extraction and PCR assay development. Being able to speak fluently about these topics will showcase your expertise and passion for the field.
We think you need these skills to ace R&D Project Manager - IVD
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in R&D project management, particularly within the IVD or medical device sector. Emphasise your technical expertise in PCR-based assay development and any regulatory knowledge you possess.
Craft a Compelling Cover Letter: Write a cover letter that specifically addresses the key responsibilities outlined in the job description. Showcase your project management skills and provide examples of how you've successfully led similar projects from conception to regulatory approval.
Highlight Relevant Qualifications: Clearly state your educational background, especially if you hold an advanced degree in Molecular Biology, Biotechnology, or a related field. Mention any certifications in project management, such as PMP or PRINCE2, to strengthen your application.
Showcase Communication Skills: Since excellent stakeholder management is crucial for this role, include examples of your communication and leadership skills. If you are fluent in German and English, make sure to highlight this in your application.
How to prepare for a job interview at Barrington James
✨Showcase Your Technical Expertise
Be prepared to discuss your knowledge of RNA/DNA extraction, PCR-based assay development, and any relevant experience in molecular diagnostics. Highlight specific projects where you applied these skills, as this will demonstrate your capability to manage R&D projects effectively.
✨Understand Regulatory Requirements
Familiarise yourself with IVDR regulations and the approval process for IVD medical devices. Be ready to explain how you've navigated regulatory compliance in past projects, as this is crucial for the role.
✨Demonstrate Project Management Skills
Prepare examples that illustrate your ability to plan, execute, and oversee complex R&D projects. Discuss how you manage timelines, budgets, and resources, and be ready to talk about any project management certifications you hold.
✨Highlight Cross-Functional Collaboration
Emphasise your experience working with diverse teams, including R&D, regulatory affairs, and manufacturing. Share specific instances where your collaboration led to successful project outcomes, showcasing your stakeholder management skills.
