DDC Engineering Coordinator

Role Overview

As a Medical Device Development Coordinator at Gedeon Richter Plc., you will play a crucial role in bridging pharmaceutical expertise with cutting-edge medical device technology. This position is integral to our mission of developing innovative combination products, including advanced delivery systems like pre-filled syringes, autoinjectors, and pens, especially when combined with biological drugs. You will be at the forefront of managing and coordinating the development process, ensuring that our products are not only effective but also compliant with the highest standards of safety and regulatory requirements.

Key Responsibilities

• Spearhead development tasks for combination products, ensuring seamless integration of device and drug
• Prepare and compile comprehensive medical device development documentation, with a keen focus on protocols and reports in English
• Navigate and implement relevant regulatory frameworks, including MDR, ISO13485, and 21 CFR Part 4, ensuring compliance and excellence
• Foster dynamic communication across cross-functional teams, including quality control, assurance, regulatory affairs, formulation development, and more
• Establish and sustain relationships with external partners, coordinating development activities to align with our ambitious goals

What we are looking for

• A degree in Pharmacy, Chemistry, Chemical Engineering, or a relevant field (such as Packaging or Mechanical Engineering)
• Proven experience in medical device development or packaging development
• Exceptional project management skills, with a track record of successful execution
• Fluency in English, both written and spoken, is essential

We offer

• Extensive benefits package (cafetera, stock program, private life insurance)
• Training and development opportunities
• Medical services (Medicover) 
• Various sport and health opportunities (gym, swimming pool, AYCM)
• Challenging, responsible professional work
• Long-term employment in an innovative and secure workplace