Regulatory Affairs Specialist

Bio-Rad a worldwide company with a presence for over 70 years is seeking an experienced Regulatory Affairs Specialist at its Budapest site. Managing the regulatory affairs in multiple countries, the Regulatory Affairs team is instrumental in ensuring timely access to the market and maintaining available products that will meet the needs of our customers while maintaining compliance to applicable regulations. The candidate will be part of the EMEA RA Team in the Bio-Rad office in Budapest, supporting the preparation, organization, and tracking of regulatory submissions for specific countries in EMEA. Beyond the candidate performs Regulatory Surveys to assure continuous compliance of products provided to customers, communicates and documents potential field actions and recalls with customers and partners. 

How you'll make an impact:

• Responsible for the registration of new products to ensure timely marketing or maintain current registrations and renewals.
• Prepares and coordinates completion and filing of internal documentation required to support Adverse Event Reporting. 
• Prepares and coordinates completion and filing of internal documentation required during Field Corrective Action or recalls.
• Provide regulatory support for medical devices already on the market during tenders and internal requests.
• Provide regulatory guidance to local and global stakeholders.
• Interact with regulatory authorities as well as Bio-Rad divisions located in the United States, France, Germany, Switzerland, United Kingdom and Asia Pacific.
• Participate in audits and inspections of regulatory bodies and assist in the dissemination of information as required.
• Prepares, files, and submits responses to external quality surveys and questionnaires. 
• Write and maintain standard operating procedures for regulatory affairs. 

What you bring:

• Bachelor's degree or equivalent in chemistry, biology, biochemistry, microbiology, immunology or related field.
• Thorough understanding of ISO 13485 standard, Good Distribution Practices (GDP)  for medical devices distributed by Bio-Rad.
• Good knowledge of the European Medical Devices Regulations.
• Certification in regulatory affairs is an asset.
• Excellent communication skills, including negotiation and persuasion.  Knowledge of English is mandatory for frequent communications with partners outside Hungary.
• Strong documentation and planning skills.
• Ability to work independently and in a team.
• Strong critical thinking and problem-solving skills.
• Customer focus.

Required Experience

• At least two years of experience in regulatory affairs of in vitro diagnostic medical device industry or working in a related regulated environment (Pharmaceutical/GMP or ISO 13485).
• Experience in blood banking would be an asset.
• Experience working with SAP and ERP systems is an asset.

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)