Beschreibung
Senior Regulatory Affairs Specialist - Medical DevicesWe have a new opportunity for a regulatory affairs expert with prior experience in medical devices to support the team in creation and maintenance of Technical Documentation, supporting compliance to European Council Directive 92/42/EEC or Regulation as applicable.
Tasks:
- Ensure the company's products comply with the regulations set up by government agencies
- Advise engineering and manufacturing on regulatory requirements
- Assist 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
- Support maintenance of regulatory files and tracking databases
Requirements:
- Strong experience in Medical Device Industry and Regulatory Affairs.
- Strong knowledge of ISO 13485 and ISO 9001, QSR
- Knowledge of MEDDEV guidance documents applicable to Medical Devices products and processes
- Strong understanding of Risk Management process, label and labelling, change management
- Understanding requirements of current Council Directive 93/42/EEC
- Familiarity with Technical Documentation structure according to STED and as required by Medical Device Regulation
Technically versed in computer software such as MS Word, Powerpoint.
Please send your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.