Job Information
About the Position
Introduction
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.
Overview
Job Summary
The Junior Regulatory Engineer supports the Regulatory Engineering team in the preparation, maintenance, and organization of quality and regulatory documentation for IVD medical devices.
The role will work in close colloboration with all R&D groups and functions, while focusing on precise execution of documentation tasks. This will involve coordination across functions, and supporting regulatory activities under guidance of experienced Regulatory Engineers.
Responsibilities
Key Accountabilities
- Regulatory & Documentation Support
- Supporting the assessment of IVD medical device feasibility against applicable regulations in targeted markets, under supervision
- Contributing to the preparation and maintenance of regulatory documentation (e.g. Design History Files, Technical Documentation)
- Supporting the maintenance of regulatory profiles for assigned IVD medical devices
- Assisting in tracking regulatory requirements
- Supporting regulatory submission and approval activities under guidance
- Product Regulatory Support
- Supporting assigned product families with regulatory documentation and planning activities
- Contributing to the preparation and maintenance of Technical Documentation / Technical Files
- Supporting Performance Evaluation and PMPF documentation activities
- Collaboration with Quality Management and R&D
- Supporting assigned product families with regulatory documentation and planning activities
- Supporting in creation and/ore regular revision of internal procedures
- Contributing to the preparation and maintenance of:
- Technical Documentation / Technical Files
- Post Market Surveillance (PMS) documentation
- Supporting Performance Evaluation and PMPF documentation activities, without ownership responsibility
Qualifications
Minimum Knowledge & Experience required for the position
- Minimum Knowledge & Experience required for the position:
- BSc with relevant experience in Life science or related field
- 1-3 years experience in a regulated environment (medical devices, IVD, pharma, or similar) or strong motivation to develop in regulatory affairs
- Initial exposure to quality systems or regulated documentation is an advantage
- Structured, diligent, and detail‑oriented working style
- Ability to work independently on assigned tasks while seeking guidance when needed
- Good written and spoken English
Skills & Capabilities
- Required
- Strong attention to detail and documentation quality
- Ability to organize, track, and maintain complex documentation sets
- Basic project coordination skills (tracking tasks, deadlines, dependencies)
- Analytical mindset and ability to follow defined processes
- Reliable, precise, and conscientious working approach
- Advantageous
- Exposure to ISO 13485 or regulated quality systems
- Background in molecular biology, genetics, or immunology
- Exposure to clinical or performance studies
- Familiarity with document management systems
Travel Requirements
5% - Occasional travel as required (typically limited; approx. 1 week per quarter or less)
What we offer
- Performance-related annual bonus
- Cafeteria with optional elements (Gross 45.000 HUF per month),
- Laptop
- Free coffee and beverages
- Free parking
- Pleasant office and family atmosphere
- Challenging and innovative work
- We care for your work-life balance
- Company events
If you are interested in constantly learning and being challenged on a daily basis, we encourage you to submit your resume or CV.
Werfen appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V.
www.werfen.com
