Ra Manager
il y a 4 jours
An international medical device/pharma company is looking for an RA Manager to join the RA team and will work closely together with QA and R&D. The Regulatory Affairs activities worldwide are coordinated by the Belgian office as well for the pharmaceutical as medical device submissions meaning you will have a better helicopter view and will have a bigger responsibility.
It is a small office so this means that you will have closer contact with everyone which will give you faster decisions and you will not feel like a number. You will not manage a team but you will get extra responsibilities like supporting in strategic decisions and get more autonomy which will be a good next step in your career.
**Responsibilities**:
Review updates of the Technical Documentations
Coordinate Risk Management Process
Point of contact for authorities and notified bodies
Provide regulatory input in product life cycle process
Implement and Improve internal record systems for example regulatory files
Support in research and evaluation of regulatory guidelines, policies,
Assist in development of Regulatory strategy
Support investigation and evaluation of regulatory history, guidelines, policies,
Collaborate with other departments such as Quality Assurance, R&D,
**Requirements**:
Master Degree in Life Sciences or Engineering
Several years of experience in Regulatory Affairs for the pharmaceutical industry
Experience with medical devices and knowledge of MDR is a big plus
Experience with international or global submissions (EMA, FDA, APAC, )
Fluent level of English
**Benefits**:
Market rate basic salary
Attractive benefit package
Flexible working from home policy
Diverse job activities and opportunity to develop in regulatory affairs
Join a team with a good atmosphere and who organise after work activities
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 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.
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