Description
Leader Regulatory Affairs (m/w/d)
Medical Devices
Thüringen
My client located in Thüringen is an international medical technology manufacturer, who offer a wide range of unique and innovative products to the global market. You will have the opportunity in this role to step into a leading position that offers an attractive salary, internal and external training, flat hierarchies and short decision paths. This will most certainly be a positively challenging task in a forward-thinking company.
Your Role:
* Leading a team of 6/7 (RA / QM / QS)
* Ensuring an effective implementation of DIN EN ISO 13485, MDR
* Continuous development of the QMS
* Creation and maintenance of the technical documentation, taking into account the applicable standards and guidelines (medical devices class I-IIb)
* Planning, coordination and implementation of national and international approvals for medical devices
* Participation in product development/project management and in the product life-cycle with regulatory topics
* GAP analysis for changes to standards, including the definition of measures
* Participation in the planning, implementation and evaluation of clinical studies
Your Profile:
* Successfully completed studies in a technical of life science related field
* At least 3 years professional experience within Regulatory Affairs for medical devices (or Quality Management/Assurance)
* Sound knowledge of the medical device industry as well as the relevant standards/guidelines
* Strong leadership skills
d.perkins@sciproglobal.de
+49 89 2109 4906
