NL - - Netherlands, NL - Netherlands - Gelderland - Nijmegen
£Neg
Ref: 312343_1644234897
Permanent
Regulatory Affairs Manager in a family owned company!
My client is a rapid growing family owned company that is looking for a Regulatory Affairs Manager to join their team.
Expand your profile with people management experience as you will build your network on an international level. Their products are a true benefit for the end use. This is something you will take home with you every day and gives you a sense of pride.
Benefits:
• Fast growing company
• Great opportunity to develop
• Grow with the company
• Small company
• You will know everyone
• You will feel at home quickly
Responsibilities:
• You will need to maintain current knowledge of regulations, legislation, best practices and guidelines related to regulatory compliance in relevant jurisdictions.
• You will be monitoring changes to applicable legislation and regulations. Identify impact to the business.
• You will be managing key regulatory initiatives to drive continuous improvement.
• You are going to assess the regulatory impact regarding introduction of new products and changes to existing products and/or processes.
You will inform the Notified body/Regulatory authorities on changes which are notifiable under applicable regulations.
• You are going to prepare regulatory submission regarding new products, product changes and registrations as required for the relevant jurisdictions.
• Register medical devices in the European database and maintain information in this database in accordance with the MDR 2017/745 requirements.
Requirements:
• You need to have either a a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline,
• You have at least one year of management experience in regulatory affairs relating to medical devices
• You have three years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
You have a thorough understanding of MDD - MDR.
• You have knowledge of Quality management systems (ISO 13485)
• You have experience in in dealing with scientific data
• Excellent knowledge of Dutch and English (Preferable knowledge of French and German)
• You have good communication skills
• You must be interested to work in a small and effective team
NonStop is one of the largest and fastest growing specialised life-sciences & Med-tech recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland, Romania, Luxembourg, US and the Czech Republic and we hold labour leasing licences for all EU8 countries. Please visit our website for a full list of the niche markets we cover.