Quality System Specialist (PMPF Analyst) - fixed-term

The Post Market Performance Follow-up (PMPF) Analyst will be responsible for maintaining accurate documentation of all post-market activities in accordance with internal policies and external regulatory expectations. They must stay updated on relevant changes to international guidelines and proactively recommend updates to procedures when necessary to ensure continued compliance. Analysts play a critical role in ensuring ongoing product safety and effectiveness through data collection and analysis.

Please note that this opportunity offers a fixed-term position until the 31st of December 2026

How You’ll Make an Impact:

• Execute PMPF deliverables and oversee the generation/scheduling of PMPF reports.

• Coordinates the collection of various post-market sources, including customer feedback, complaint data, and clinical registries. Systematically review this information to identify trends, detect potential safety signals, and inform risk management.
• Collaborate closely with internal stakeholders to facilitate knowledge sharing and ensure alignment with regulatory requirements.
• Continuous monitoring of product performance and prompt escalation of any significant findings to relevant departments.

• Maintenance of Post Market Performance Follow-up Plans, Performance Evaluation Reports, and other related documentation.  

• Ability to synthesize complex data into clear and concise reports will be vital in supporting regulatory submissions and ongoing quality initiatives.
• Strong research, writing, and communication skills, as well as a solid understanding of scientific concepts.
• Review and analyze scientific literature and summarize findings in applicable protocol reports.
• Guarantee all PMPF deliverables are executed and aligned according to the Periodic Safety Update Report Publication timeline.

What You’ll Bring:

• BS in a science-related field (Biochemistry, Biotechnology, Chemistry, or related field)
• Ability to resolve complete situations that require a logical, analytical, and methodical approach.
• Knowledge of immunoassays, infectious diseases, bacteriology, and related diagnostic techniques/instruments
• Minimum of 1 year laboratory experience
• Experience in the in-vitro diagnostics industry preferred.
• Familiarity with IVDR regulation 2017/746
• Advanced English level: Able to communicate effectively in English and in writing
• Proficient use of applications: Word, Excel, PowerPoint, OneDrive, SharePoint, 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)