Regulatory Affairs Specialist
The candidate is part of the EMEA RA Team in the Bio-Rad office in Budapest and will be the UK RA Representative and support Poland, Greece, Israel, Nordics, BeNeLux, and Czech Reublic. Preparation, organisation 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, commuinicates and documents potential field actions and recalls with customers and partners.
Founded in 1952, Bio-Rad has developed into a recognized global leader in the growing life science research and clinical diagnostics markets. We have built a strong team of over 8,000 employees and a robust network of operations that serves over 150,000 customers worldwide.
Bio-Rad employees share a common mission: To “Advance discovery and improve lives.”
Responsibilities:
- Functions as UK RA Representative for the company
- Writes and/or assembles international regulatory submissions.
- 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 and coordinates completion and filing of internal documentation required during Field Corrective Action
- Prepares, files, and submits responses to external quality surveys and questionnaires
- Participates in regulatory agency inspections as needed.
- Implements department improvement projects.
Qualifications:
- Bachelor’s degree or equivalent in Biology, Chemistry, Medical Technology, or related field.
- 5+ 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.
What Bio-Rad Can Offer To You :
- A dynamic environment where your innovative ideas are always welcome
- A collaborative community where your professional goals and work are supported by encouraging supervisors
- Competitive salary and cafeteria
- Annual bonus
- Private Health Care Services – unlimited examinations, checkups in numerous specialties free of charge
- Life and accident insurance
- Employee Referral Program with remarkable referral bonus
- Hybrid working model (3 days onsite and 2 days home office. Our office is located in Budapest, Futó u. 47, 1082)
