Regulatory Affairs Specialist (m/f/x) | Medical Devices
In this position you will be mainly responsible for managing regulatory aspects of medical devices, focusing on compliance, regulations, and published guidance documents. Furthermore, you will coordinate and manage translations and approvals by local regulatory experts and work as part of projects teams to create launch materials for new products and indications.
What are your tasks as "Regulatory Affairs Specialist (m/f/x)"?
- You will be the coordinator of the risk management based on ISO 14971, in particular risk analysis according to DIN EN ISO 1497
- You will monitor the changes in the regulatory environment of medical devices and laboratory equipment as well as their evaluation
- You will responsible for the evaluation of regulatory requirements (e.B standards, laws)
- You will be check the deadline monitoring in the context of approval projects
What does the position as "Regulatory Affairs Specialist - (m/f/x)"? offer to you?
- Exciting projects & personal development
- Remote Working and Flexible work hours
- Sport and health benefits
- International and friendly Environment
What requirements do you need for "Regulatory Affairs Specialist (m/f/x)"?
- University degree in technical or life science field
- At least 2 year's experience in regulatory affairs for medical devices
- Relevant professional experience with the technical interpretation and implementation of legal requirements (e.B. Low Voltage, Machinery, EMC Directive)
- knowledge of EU medical device legislation and other international regulations
- Excellent language skills in German and English (written and spoken)
- Excellent communication and organisational skills
About the client?
Our client is an innovation leader of validated medical devices and services. They are an active company with a value-oriented corporate culture. The absolutely precise control of all parameters, that they offered, make them a market leader in Medical Device area.
Are you interested in such company? Then you should apply now! If you would like to receive Information, I would be happy to let you more about it and other opportunities:
Contact for application:
- E-Mail: firstname.lastname@example.org
- Tel: +49 (0)89 / 26200311
- LinkedIn: https://www.linkedin.com/in/marianna-furchÃ¬-90872750/