Description Amaris is an independent, international Technologies and Management Consulting Group. Created in 2007, Amaris is already established in over 45 countries and supports 500 clients worldwide throughout their projects’ lifecycle. Our expertise covers 5 areas of innovation: Business and Management, IT/IS, Telecom, Engineering and High Technologies, Biotech and Pharma. With 60 offices across the World, the Group offers proximity support to its clients in all their locations and many opportunities of international careers for employees.In 2016, Amaris reached a turnover of 140 million euros, 2650 employees and the ability recruit 1 new employee every 5 hours. We expect to triple our workforce within the next years and reach an international leader position in independent consulting. Your Role You will join Amaris as a consultant and be part of a team coordinated by your Manager. Together you will design technical and/or management solutions for our clients in pharmaceutical, medical devices and biotechnology industries. You will be present on client’s plant to work on mid and long term project in Regulatory Affairs. As a Regulatory Affairs Consultant you will be working in a team of consultants who are experts in the specific field of: Pharmaceutical, Medical Devices or Biotechnology; within these markets they have a specialization in: Quality Assurance, Regulatory Affairs, Manufacturing, Clinical Affairs or Medical Affairs.Your role as RA consultant will be to contribute to implementation and optimization of the RA policy of the client and to ensure that manufactured product comply to quality, legal and client’s requirements. In this position you will be responsible for a variation of Regulatory aspects within the projects of our clients such as: •Prepare and update technical regulatory documents according to documentation standard •Creation, review and approval of regulatory requirements and technical files •Assessment and approvals of change requests •Maintain regulatory documents in document-management systems (e.g., Documentum) and document-sharing systems (e.g., SharePoint) •Define and maintain an overview of the regulatory requirements and changes •Prepare document packages for regulatory submissions •Release of communication material (IFU, leaflets, brochures) Profile :You have received a scientific education: engineer, chemist, biologist, and pharmacist or similar. You know the legal requirements for pharmaceutical industry (cGMP) and Medical Devices (ISO13485:2003, CMDCAS, J-PAL PCAR ) and have a work experience in such environment. You are proactive, have good communication skills, and are capable of working in a multidisciplinary team towards a common goal. You are proficient in English (spoken and written) and Dutch is a plus!