Regulatory Affairs Manager

The Regulatory Affairs Manager will be responsible for the development, implementation, and on-going improvement of programs in the areas of regulatory compliance, document control, and product registrations/ submissions for the products manufactured and distributed by Bio-Rad Laboratories in the territories under our responsibility. Directs and supervises a team of Regulatory Affairs Specialists and interacts with internal and external partners to achieve performance, customer satisfaction, and expense management objectives. Assigns territories and accounts to the team and provides support.  Manage recruiting, training, and development of the team and support personnel. Plans and executes service and support programs to achieve the business objectives established with management.

How You’ll make an impact:                                                                    

• Responsible for the registration of new products to ensure timely marketing and maintaining annual renewals.
• Reviwes and approves regulatory documents prepared by department personnel. Provide regulatory support for medical devices already on the market.
• Ensure that adverse events and field actions/recalls are properly managed and communicated according to applicable requirements.
• Provide regulatory guidance to local and global stakeholders.
• Interact with regulatory bodies as well as Bio-Rad divisions located in the United States, France, UK, Germany, Switzerland and Asia Pacific.

What You’ll bring:    

• Bachelor's degree or higher in chemistry, biology, biochemistry, microbiology, immunology or related field.
• 5+ years’ relevant regulatory experience with medical devices or equivalent combination of education and experience
• Good knowledge of the European Medical Devices Regulations.
• Experience supervising 1-5 direct reports an asset.
• Experience with SAP is an asset.
• Excellent oral and written skills in English. Knowledge of English is mandatory for frequent communications with partners outside Hungary.

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, BKK monthly 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 and 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)