Senior Regulatory Affairs Specialist Medical Devices

Beschreibung

Senior Regulatory Affairs Specialist Medical Devices - 12 months contract Switzerland
Responsibilities:
Support the LCM Regulatory Affairs group in creation and maintenance of technical documentation, supporting compliance with the European Council Directive 92/42/EEC or Regulation , US FDA 510(k) submissions, country registrations on a world-wide basis.
* 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
* Supporting maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information concerning current, pending, and future approvals and renewals
* Capturing and verifying regulatory product characteristics to support logistic and supply chain efforts on a global scale
* 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
* Supporting team's daily operations of regulatory processes to ensure compliance with routine regulatory reporting obligations
* Providing progress of work-plans and the status of key project deliverables
Requirements:
* 5 years of experience in European Medical device industry especially with regulatory, quality or engineering
* Strong knowledge of ISO 13485 and ISO 9001, QSR
o Medical Devices applicable requirements, especially Council Directive 93/42/EEC and Regulation , as they pertain to technical documentation
o MEDDEV guidance documents applicable to Medical Devices products and processes
* knowledge of FDA requirements
o registration requirements in further global markets would be an asset

Michael Bailey International is acting as an Employment Business in relation to this vacancy.