Leader Regulatory Affairs (m/w/d)

Lawrence Harvey

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Job ID :


Company Type :

Staffing Firms

Industry :

Medical and Nursing

Education Level :


Address 1 :

Western Europe,Germany,Thüringen,

Key Skills :

regulatory affairs, medical devices, IVD, quality, quality management, IVD, ISO 13485

Salary :


Date Posted :

28 Aug, 2019

Company Name :

Lawrence Harvey

Location1 :


Job Category :

Regulatory Affairs Jobs

Experience :


Job Type:


Travel Amount:



Leader Regulatory Affairs (m/w/d)

Medical Devices


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


+49 89 2109 4906

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