Regulatory Affairs Specialist Medical Devices
Posted on Jul 4, 2021 by Michael Bailey Associates - Zurich
Regulatory Affairs Specialist Medical Devices Switzerland Contract
Our client has an urgent need for and experienced Regulatory Affairs Specialist to join their busy team to support creation and maintenance of technical documentation in compliance with European directives for medical devices.
* Ensuring that the company's products comply with the regulations set up by government agencies
* Advising engineering and other support functions, as well as manufacturing on regulatory requirements
* Assisting with reviewing of product and process documentation for assigned projects to ensure compliance with change control requirements to aid in determining any required regulatory activities
* Creating, reviewing and maintaining regulatory related technical documentation
* Working with cross-functional teams to obtain relevant information and subsequent review of submission content as needed; assisting in review of international product technical documents, marketing and labeling materials
prior experience in European Medical device industry especially with regulatory, quality or engineering
Knowledge of ISO 13485 and ISO 9001,
Medical Devices applicable requirements, especially Council Directive 93/42/EEC and Regulation 2017/745, as they pertain to technical documentation
MEDDEV guidance documents applicable to Medical Devices products and processes
FDA regulations requirements
This is 6 months contract initially with strong possibility for extension for another year.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.