As Regulatory Affairs Engineer, you role will be to implement the company’s regulatory strategy to guarantee the application of regulation for the development, market access and distribution of Stilla’s products.

Regulatory missions :

• Ensure that products meet the regulatory requirements
  • Train the teams on normative and regulatory requirements
  • Work with the different teams on the application of regulatory and normative requirements
  • Coordinate with expert laboratories the tests required to demonstrate regulatory and normative compliance

• Ensure the submission of registration files for in vitro diagnostic medical devices
  • Generate and update regulatory files in accordance with the current regulations for the targeted markets (CE - US etc.)
  • Support distributors in the registration of our products in targeted markets (e.g. China)

• Coordinate PMS / PSUR processes for Stilla products
  • Ensure the deployment of PMS and reactovigilance processes in Stilla
  • Ensure post market regulatory actions (FSN - FSCA)
  • Communicate with the competent authorities

• Ensure regulatory and normative watch
  • Anticipate regulatory and normative changes
  • Analyze the impact of these changes on Stilla’s activities
  • If necessary, set up an action plan to implement these changes and train the teams

• Support the department’s actions beyond regulatory affairs as defined by the hierarchy

Knowledge of the EN ISO 13485:2016 standard
Knowledge of the IVD-D 98/79/CE regulation
Knowledge of the IVD-R 2017/746 regulation.
Knowledge of EN ISO 14971, EN IEC 61010, EN IEC 62304, EN IEC 62366 standards
Knowledge of US 510K registration procedure.
3 to 5 years experience
Master in the field of medical devices - quality / regulatory affairs or biology - similar engineering degree
Fluent in english