Clinical Research Associate
Employer · Bio-Rad Laboratories
Biologist
Other health professional
Legal specialistFlexibleFull-timeTransportMealsBudapest District VIII, Futó u. 47, 1082
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.
Tasks
- 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.
Conditions & benefits
Life and accident insurancePrivate Health Care Servicesunlimited examinations, checkups in numerous specialties free of chargeCompetitive salary and cafeteriaCommuting allowance100% commuting allowance for non-Budapest residents, monthly BKK passAnnual bonusAnnual salary reviewMarriage and childbirth allowanceSchool start allowanceLoyalty awardEmployee Referral Programwith remarkable referral bonusAll You Can Move contract possibility/gym facility usagefor free of chargeHybrid working model3 days onsite and 2 days home office.
Requirements
- 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