RA Officer

작업 내용

RA Officer in ambitious company
My client is an family owned international company that has big plans.
Building on last year’s great results you will work with a strong product line with others in your team to divide the work and learn from each other. This gives you a great opportunity to progress within the company as they are growing rapidly.

Benefits:
Mid-sized company
Flat organisation
Better way of communication

2 products in the pipeline
Build the technical files
Implement the MDR

Responsibilities:
You will be supporting the Regulatory Affairs department in preparing product technical dossiers and other regulatory documents for registration submissions in and outside EU
Create support for the Regulatory Affairs department in keeping product technical dossiers and other regulatory documents up to date during the life-cycle of the company’s products
Be helpful with the complaints and to maintain the CE and ISO certificate requirements
You will participate in the implementation of the new Medical Device Regulation
You will be supporting the regulatory compliance of communication activities and materials (brochure, presentation, packaging material etc.) regarding the company’s products, in close collaboration with marketing and sales

Requierements:
You need a Master’s degree in Industrial Pharmacy/Pharmaceutical Sciences or related scientific Master
If you have a first professional experience in international regulatory affairs is added value .
You must be willing to acquire knowledge of regulatory affairs related to EU or FDA or other non-EU regulations
You have the ability to read and understand competent authority regulations, guidance documents, test reports and technical/chemical product information
You have strong time and project management skills/knowledge is an asset
You need to be proficient with all Microsoft Office applications (Word, Excel, Power Point, Project, etc.), if you have experience in Data capturing tools is a plus
You are a self-motivated team worker
You know how to share recommendations, experiences and best practice with colleagues
You have the gift to creating enthusiasm and initiative to make things happen
You are a great listener to others and know how to give constructive feedback
You are fluent in English, both written and spoken, another language is an asset.

If this job appeals to you please apply here or on the NonStop Consulting website or send it to me, Gilson Heitinga, on my Linkedin. If you are not available but you know someone that would be interested, please forward this to them and help the people in your network.

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.