Amaris is an independent, international Technologies and Management Consulting Group. Created in 2007, Amaris is already established in over 50 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 65 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 2017, Amaris aim to reach a turnover of 180 million euros, 3500 employees and the ability to recruit one 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 quality regulatory affairs consultant and be part of a team coordinated by your manager. Together you will design technical and management solutions for our clients in the lifescience industry. You will be present on the client’s plant to work on mid and long term projects. As a quality regulatory affairs consultant you will be working in a team of consultants who are experts in the lifescience industry.

As a quality regulatory affairs consultant, you will be responsible for:

• Preparing and updating technical regulatory documents according to documentation standard.
• Creating, review and approval of regulatory requirements and technical files.
• Assessment and approvals of change requests.
• Maintenance of regulatory documents in document-management systems (e.g., Documentum) and document-sharing systems (e.g., SharePoint).
• An overview of the regulatory requirements and changes (definition and maintenance).
• Preparation of document packages for regulatory submissions.
• Release of communication material (IFU, leaflets, brochures).

Profile

• You have received an engineering degree or equivalent.
• You know the legal requirements for lifescience industry (cGMP)
• You have proven experiences in one of those above roles
• You are proactive, have good communication skills, and are able to change people mind-set in the way of efficient working.
• You are proficient in Dutch and English (written, spoken)!