Group Regulatory Affairs Specialist

工作内容

Ontex is a leading international producer of personal hygiene solutions for babies, women and adults. We distribute in more than 110 countries through leading retailer private labels, as well as under our own brands. The group employs over 10,000 employees, spread around the world. Ontex is listed on Euronext Brussels.

Our people are our most valuable asset. To support and reinforce our Quality team we are looking for a Group Regulatory Affairs Specialist.

Main Responsibilities

• Follow-up regulatory requirements linked to our products and processes and embed these requirements in the quality management system
• Give guidance to the local teams on site and in sales related to regulatory requirement (i.e. QA agreements, customer questions, awareness trainings …)
• Review local Sales and Marketing material (labels, artworks and advertising) to ensure applicable quality and regulatory requirements are met.
• Assess the regulatory impact of change controls.
• Assist R&D team on regulatory requirements during design and development process
• Coordinate activities linked to the Medical Device Regulation:
• Support in RA documentation, including Technical Documentation and clinical investigations documentation.
• Support implementation of Post Market Surveillance
• Reportable events reported within time lines to competent authorities
• Participate in regulatory audits/internal audits and inspections as appropriate
• Maintains all RA related databases (i.e. GUDID, EUDAMED,…)
  

Requirements

• Master degree in engineering / science (or equal through experience)
• At least 5 years of relevant experience, with a focus on regulatory affairs of Medical Devices Class I / II
• Knowledge of Regulatory requirements as MDR, REACH, SUPD, FDA, etc.
• Knowledge of Quality management systems as ISO13485, MDSAP, QSR, etc.
• Able to push projects forward and take full accountability
• Able to create business partners within the organization
• Strong communication skills and fluent in English, any other language is considered as an assets
• IT skills – Sharepoint / Microsoft applications
• Team player
  

Interested in a job at Ontex, but still have a question? Contact our HR department (