Regulatory Affairs Manager

• Medical Device Start Up (Vascular)
• High valued and awarded

Medical Device Start Up (Vascular)

• Lead the Regulatory strategy for the development, manufacture and commercialisation of the company products (Vascular Medical Device Class III)
  


• Represent the company before the Competent Authorities and the Notified Body.
  


• Keep the technical documentation of the products updated in accordance with the National, European, United States and any other jurisdiction where the Company carry out its activities.
  


• Actively collaborate in internal and external audits and inspections of the Competent Authorities, the Notified Body, customers or manufacturers outsourced.
  


• Intervene in the Risk Management and Design Control processes.
  


• Maintain up-to-date knowledge of the regulations published and applicable in the field of medical devices, as well as providing support to the different departments.
  


• Inform Management of any risk situation for the company related to the development, manufacture and marketing of products.
  

• Fix contract


• 45.000€ - 50.000€ + 10% bonus


• Valles Occidental based


• 1 day/week home office

• Health Sciences Degree
  


• Specific training in Regulatory Affairs and Quality Assurance. Very valuable Postgraduate or Master related.
  


• Minimum of 5 years experienced in Medical Device Regulatory
  


• High level of spoken and written English.
  


• Person accustomed to working in a team, methodical and organised