Beschreibung
Would you like to work in a dynamic and fast growing environment? Then apply and join a highly motivated and innovative Regulatory Affairs team at our Burgdorf site as
# Regulatory Affairs Manager | 80 - 100% #
Ref. No. 7137
Location:
Burgdorf
| Hybrid
Help us bring to market state-of-the-art medical technology solutions by optimizing processes and ensuring quality through your structured approach.
### Your main tasks ###
* Manage regulatory responsibilities associated with the development, support, and deployment of combination products and medical devices within the business area delivery systems
* Manage the development and implementation of regulatory strategies
* Support and prepare worldwide product submission documents
* Partner with business stakeholders on different levels
* Support life-cycle management activities
* Review quality agreements with customers on regulatory aspects
* Cooperation in QMS ISO 13485 and 21 CFR 820 audits
* Lead or support continuous improvement initiatives
### Your profile ###
* University degree preferably in Engineering or Natural/Medical Sciences or equivalent experience
* At least 2 years of professional experience in Regulatory Affairs with focus on combination products and/or medical device
* Project Management competences preferred
* Excellent organizational and people skills
* Ability to work in an international cross-functional organization
* Very good English knowledge (C2), German is a plus (B1)