Job Description
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
We are seeking a highly skilled and motivated IVDR Scientist to join our Research and Development (R&D) team. The ideal candidate will have a strong background in In Vitro Diagnostics Regulation (IVDR) and experience in scientific research and product development within the medical device industry. You will play a crucial role in ensuring compliance with IVDR regulations and driving the successful development and commercialization of our innovative diagnostic products.
What will you do
Stay up-to-date with the latest IVDR regulations and guidelines to ensure adherence throughout the product development lifecycle.
Collaborate with teams to develop and implement regulatory strategies for product registration and approval.
Conduct research and literature reviews to support the development and validation of products, ensuring scientific rigor and accuracy.
Contribute to the design, development, and optimization of diagnostic assays and devices, considering IVDR requirements and industry best practices.
Plan, implement, and document verification and validation studies to demonstrate the performance and safety of diagnostic products in accordance with IVDR guidelines.
Prepare and review documentation, including technical files, design dossiers, and labeling, to support IVDR compliance and regulatory submissions.
Collaborate with R&D, Quality Assurance, and Regulatory Affairs to ensure alignment.
Find opportunities for process optimization, cost reduction, and quality improvement within the IVDR compliance framework and contribute to their implementation.
How will you get there
Bachelor's, Master's, or Ph.D. degree in Life Sciences, Biomedical Engineering, or a related field.
Minimum of 3 years of related experience focused on IVDR compliance, scientific research, and product development within the field of in vitro diagnostics.
Solid understanding of IVDR regulations, guidelines, and requirements, with hands-on experience
Strong analytical problem-solver who haswith the ability to interpret complex scientific data and make informed decisions.
Excellent written and verbal communication skills, with the ability to effectively communicate complex scientific concepts to both technical and non-technical people.
Proven ability to collaborate optimally with teams, demonstrating strong interpersonal skills and the ability to work in a fast-paced, dynamic environment.
Meticulous attention to detail and accuracy in research, documentation, and compliance activities.
Familiarity with other relevant regulations and standards, such as ISO 13485 and FDA regulations, is preferred.
Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com
Compensation and Benefits
The salary range estimated for this position based in California is $123,800.00–$170,000.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards
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