Regulatory Affairs Specialist

Our company is involved in the supply of high-quality products and services intended for diagnostic laboratories. Independence, innovation and commitment are the fundamental values that permeate our company culture, as well as a strong orientation towards our customers and a multicultural environment. 

Our new colleague will prepare, organize and submit regulatory materials within standard guidelines that adhere to established policies and procedures. 

 

How You will make an impact:  

 

• You write and/or assemble low complexity domestic and/or international regulatory submissions to obtain Marketing Authorization of our IVD Medical Devices. 
• You formally track and regularly report on status of submissions pending at regulatory agencies as required. 
• You facilitate regulatory clearance of domestic regulatory submissions by supporting the interactive review process under the direction of the Regulatory Affairs Manager. 
• You respond to internal/external customer regulatory requests and provide documentation support for tenders. 
• You work closely with representatives of our subsidiaries (Latin America, Eastern Europe, Middle East, and Russia) to define the regulatory strategy and meet local requirements. 

 

What You’ll bring:    

 

• Languages: fluent in English both written and spoken 
• Good skills to analyze and synthesize technical data. 
• Good technical writing skills and can clearly present complex situations (both written and oral). 
• Ideally 1 to 3 years of experience in regulatory affairs (diagnostic industry pharmaceutical or) and have a good knowledge of regulations and standards for medical devices.  
• You benefit from a scientific university degree in biology or pharmacy (Bachelor or equivalent level) with ideal knowledge of immuno-hematology. 

 

 

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  
• 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 discount  
• Hybrid working model (3 days onsite and 2 days home office. Our office is located in Budapest, Futó u. 47, 1082) 

 

#LI-Hybrid #LI-AÁ1 

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