Clinical Research Associate

As a Clinical Research Associate, you will support the clinical performance and post-market surveillance of in vitro diagnostic products. Based in Budapest in a hybrid working model, you will coordinate clinical and performance studies, develop performance documentation, and help ensure that our products meet applicable regulatory requirements.

Working closely with cross-functional project teams, you will contribute to new product development, product improvements, regulatory submissions, and the continuous monitoring of product performance. This is an excellent opportunity to combine your scientific expertise, regulatory knowledge, and analytical skills in a role that directly supports the quality and availability of diagnostic solutions.

How You'll Make an Impact

• Execute Post-Market Performance Follow-up activities and coordinate the preparation and scheduling of PMPF reports.
• Review and analyze scientific literature, translating complex findings into clear protocols, reports, and clinical evidence documentation.
• Maintain Post-Market Performance Follow-up Plans, Performance Evaluation Reports, and other performance-related documentation.
• Coordinate the collection and evaluation of post-market data from multiple sources.
• Ensure that PMPF deliverables are completed in alignment with Periodic Safety Update Report publication timelines.
• Continuously monitor product performance and promptly escalate significant findings to the appropriate teams.
• Manage clinical studies required to establish and validate the performance of IVD products.
• Contribute clinical performance expertise to the design and development of new or improved products.
• Assess the performance impact of product and process changes and update the relevant Performance Evaluation files.
• Monitor evolving pre-market and post-market regulatory requirements, supporting project teams in understanding and applying them.

What You'll Bring

• A master's degree in Biology, Molecular Biology, or a related scientific field, ideally with a specialization in clinical studies or Medical Device and IVD Medical Device regulations.
• At least 2 years of experience in a similar position, preferably within the IVD medical device industry.
• Knowledge of immunoassays, infectious diseases, bacteriology, and related diagnostic techniques and instruments.
• Knowledge of CE requirements and harmonized standards relevant to IVD medical devices, together with familiarity with Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
• Advanced written and spoken English, with the ability to communicate scientific and regulatory information effectively.
• French language knowledge is an advantage.
• Strong scientific research and technical writing skills.
• The ability to synthesize complex scientific data into clear, concise, and well-structured reports.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external stakeholders.
• Proficiency in Microsoft Word, Excel, PowerPoint, OneDrive, SharePoint, and Teams

Who we are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Recently voted a Best Place to Work, Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.

Benefits: Bio-Rad's biggest asset is its people, and the reason why our Total Rewards deliver programs that provide value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Our robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee's work and life cycle. We're proud to offer a variety of options, including:

• Life and accident insurance,
• Private Health Care Services - unlimited examinations, checkups in numerous specialties free of charge
• Competitive salary and cafeteria
• 100% commuting allowance for non-Budapest residents, monthly BKK pass
• Annual bonus
• Annual salary review
• Marriage and childbirth allowance
• School start allowance
• Loyalty award
• Employee Referral Program with remarkable referral bonus
• All You Can Move contract possibility/gym facility usage for free of charge
• Hybrid working model (3 days onsite and 2 days home office. Our office is located in Budapest, Futó u. 47, 1082)

Legal Entity: (HUN_2035)Bio-Rad Hungary Trading LLC

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