Regulatory Affairs Manager jobs in Holyoke, MA

Overview

We're looking for a dynamic individual to join our EMEA Regulatory Affairs Team in Budapest. This is a unique opportunity for a talented Regulatory Affairs Specialist to contribute to the preparation, organization, and tracking of regulatory submissions across specific countries in the EMEA region.

The candidate will be part of the EMEA RA Team in the Bio-Rad office in Budapest and will be the UK RA Representative and support different countries in scope of the team.  Preparation, organisation, and tracking of regulatory submissions for specific countries in EMEA. Tthe candidate also performs Regulatory Surveys to assure continuous compliance of products provided to customers, and  managing RA service providers and overlook international submission status is a core task of this function as well.

How You’ll Make an Impact: 

• Writes and/or assembles international regulatory submissions.  
• Manages RA service providers 
• Tracks status of submissions pending at regulatory agencies as required.   
• Provides regulatory support for products prior to launch  
• Participates in regulatory agency inspections as needed and assists in dispersing the information as appropriate.   
• Prepares and coordinates completion and filing of internal documentation required to support Adverse Event Reporting  
• Prepares, files, and submits responses to external quality surveys and questionnaires  
• Participates in regulatory agency inspections as needed.   
• Implements department improvement projects.  

What You Bring:  

• Bachelor’s degree or equivalent in Biology, Chemistry, Medical Technology, or related field.  
• 2 years related experience or equivalent combination of education and experience.   
• Communication skills, including negotiation and persuasion.  
• Analytical, problem solving, computer, and critical thinking skills.  
• Working knowledge of UK and CE Mark IVD requirements  
• Ability to work independently.   
• Flexibility through effective planning, time management and expertise.   
• Thorough knowledge of policies, practices and procedures related to RA.   
• Knowledge of Product Labeling and Export Requirements.   
• Prior experience with SAP is preferred.  

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