Staff Scientist, R&D - IVDR

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 efficiency 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. As an IVDR Scientist, 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 and compliance throughout the product development lifecycle.

- Collaborate with internal partners, including R&D, Quality Assurance, and Regulatory Affairs to develop and implement regulatory strategies for product registration and approval, ensuring compliance with IVDR requirements and ensuring alignment and effective communication throughout the product development process.

- Conduct scientific research and literature reviews to support the development and validation of new innovate diagnostic 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 technical documentation, including technical files, design dossiers, and labeling, to support IVDR compliance and regulatory submissions.

- 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 with minimum of 3 years of experience in the medical device industry, with a focus on IVDR compliance, scientific research, and product development within the field of in vitro diagnostics.
• Hands-on experience with liquid chromatography and mass spectrometry applications and workflows.
• Strong analytical and problem-solving skills, with the ability to interpret complex scientific data and make informed decisions.
• Meticulous attention to detail and a high level of accuracy in scientific 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 visitwww.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

#StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Compensation and Benefits

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:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards