(Senior) Regulatory Affairs Manager (m/f/d)
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 Manager (m/f/x)"?
- You prepare international approval documents for substance based medical devices (Class I and II) and the corresponding European and international registration process
- You will review and approval product's documents
- You will be the contact person for internal and external customers on regulatory topics
- You are the PRRC for regulatory aspects (such as technical documentation, post-market surveillance, reporting obligations)
- You will lead responsibilities in interdisciplinary projects
- You will be the technical guidance of junior colleagues
What does the position offer to you?
- Exciting projects & personal development
- Remote Working Flexible work hours
- Pension plan and childcare
What requirements do you need for "Global Regulatory Affairs Lead (m/f/x)"?
- Bachelor's degree in scientific or health discipline, preferably M.S. or higher
- At least 2 year's experience in regulatory affairs for medical devices (class I-II) and with the health authorities at national and international level
- knowledge of EU medical device legislation and other international regulations
- Excellent communication and organisational skills
- The ability to work independently on projects and with external vendors
- Confidence and the ability to influence key stakeholders
- Excellent language skills in German and English (written and spoken)
About the client?
Our client is a strong, established business and a market leader in the Substance Based Medical Device area. Based on Over 20 years of experience in the production and use of products for the pharmaceutical, cosmetics, and life science industries.
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/