Regulatory Affairs Specialist
Jocelyn Blackham is recruiting for a Regulatory Affairs Specialist to join a company in the Medical Device industry at their site based in on a contract basis until the end of January 2022.
Regulatory Affairs Specialist Role:
- Support the Life Cycle management Regulatory Affairs group in creation and maintenance of technical documentation, supporting compliance to European Council Directive 92/42/EEC or Regulation 2017/745, as applicable, US FDA 510(k) submissions as well as country registrations on a world-wide basis
- Ensure that the company's products comply with the regulations set up by government agencies
- Assist with reviewal of product and process documentation for assigned projects to ensure compliance with change control requirements to aid in determining any required regulatory activities
Key duties will include:
- Creating, reviewing and maintaining regulatory related technical documentation
- Supporting maintenance of regulatory files and tracking databasesto ensure prompt and accurate access to company regulatory information concerning current, pending, and future approvals and renewals
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Previous experience in European Medical device industry especially with regulatory, quality or engineering
- Strong knowledge of ISO 13485 and ISO 9001, QSR
- Strong knowledge of Medical Devices applicable requirements, especially Council Directive 93/42/EEC and Regulation 2017/745, as they pertain to technical documentation
- Reasonable knowledge of FDA requirements
- Strong understanding of Risk Management process, label and labeling, change management is desired
This is an excellent opportunity to join a leading global Medical Device company
For more information or to apply for this position, please contact Jocelyn Blackham on 0041 (0) 800 106 106 or email jblackham@ckqls.ch. Please could you send any correspondence in English. Please quote reference 52246 in all correspondence.
