Regulatory Affairs Specialist - Senior
Alex Tosney is recruiting for a Regulatory Affairs Specialist to join a company in the medical device industry at their site based in Solothurn on a contract basis until the end of December 2019.
The main purpose of the role will be to support the internal 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.
- As well as country registrations on a world-wide basis, as appropriate.
Further responsibilities will include:
- Ensuring that the company's products comply with the regulations set up by government agencies.
- Advising engineering and 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 if regulatory submissions are required.
- Creation, review and maintenance of regulatory related technical documentation
- Capturing and verification of regulatory product characteristics to support logistic and supply chain efforts on a global scale.
To be considered for this position you will need the following skills and experience:
- Experience in European Medical device industry especially with regulatory, quality or engineering.
- Strong knowledge of ISO 13485 and ISO 9001, QSR, 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.
- Reasonable knowledge of FDA requirements and registration requirements in further global markets would be an asset.
- Strong understanding of Risk Management process, label and labeling, change management is desired.
- International experience preferred.
This is an excellent opportunity to join a global company.
For more information or to apply for this position, please contact Alex Tosneyon 0041 782 508 443 or email atosney@ckqls.ch. Please quote reference 46798 in all correspondence.
