For its biotechnology's partner, Kelly Life Science is looking for:
Regulatory Affairs Specialist Junior
(Permanent position)
Your mission
- You will support the department by preparing/verifying the Medical Device Technical Documentation according to the EU Medical Device Regulation (MDR) 2017/745
- You will ensure compliance of the labelling according to the regulation and applicable standards
Your responsibilities
- Support the preparation of the medical device technical documentation according to EU MDR 2017/745 requirements
- Assess the regulatory impact for the changes to existing products/development of new devices
- Ensure accurate records of product submission and registration
- Ensure regulatory review and update of the device labelling information
- Support activities related to CAPA processes
Your profile
- A Bachelor or master's degree in the medical field, life sciences or similar (or equivalent work experience in similar function)
- Basic Knowledge/understanding of the EU Medical Device Regulation (EU) 2017/745, European Medical Device Directive 93/42/EEC and ISO 13485
- Fluent (C1 minimum) in written and spoken English
Your contact at Kelly Life Science : Anais MIESZCZAK