Regulatory Affairs Executive Job Description Template
Our company is looking for a Regulatory Affairs Executive to join our team.
- Use and update regulatory information systems for planning, preparing, tracking and storing submissions to regulatory agencies;
- Assist in clinical evaluation report for Medical devices;
- Participate in regulatory team meetings and present project status updates;
- Supporting the preparation of regulatory submissions for medicinal products, particularly GX, OTC and CCG;
- provide launch readiness and other commercial project team support;
- attend and participate in local and global meetings/calls as required, and present on regulatory topics when requested;
- review and process all parallel import notifications received and liaise with the global patents department as required to respond to them;
- Routine Management of the QMS CAPA plans;
- Act as the QMS Management Representative;
- Create and manage the international Declaration of Conformity;
- Help ensure the management and update of product technical files;
- Provide support in the global registration of products;
- support EU strategy on specific projects on development/marketed products;
- actively seek to minimize risks to the business, managing risks identified and alerting the Regulatory Affairs and Quality Manager;
- monitor the status of competitor marketing authorisation’s as agreed with the local business.
- A good understanding of MDD, ISO 13485 and QSR;
- Degree in Science, Engineering or equivalent;
- Some knowledge of EU regulatory requirements;
- Minimum of two years’ experience in a similar position with experience of integrated QMS;
- Good written and oral communication skills in English and French;
- The role itself also present amazing opportunities to develop within the company whilst being surrounded by an amazing product portfolio;
- This position is based in the beautiful French Riviera and so is perfect for anyone wishing to relocate.