RA Senior Manager - Broad Leadership Role

Job content

An international medical device/pharma company is looking for a Regulatory Affairs Senior Manager to manage a small team and lead important project to success. It is a small team where you will be involved in all the Regulatory Affairs activities worldwide meaning you will have a lot more variety and will be able to learn something new every day.
Their product is a combination device so you will need to follow as well the pharmaceutical as the medical device regulations which will make it more challenging and interesting. You can also develop your skills in both fields which will add value to your professional profile.

Responsibilities:
Act as Person Responsible for Regulatory Compliance in accordance with the MDR 2017/745 regulations
Coordinate and moderate the Risk Management Process
Maintain the drug files in compliance
Assist internal regulatory review processes for product life cycle and product development
Execute and improve internal records systems especially regulatory files
Support the evaluation of regulatory impact on current and new products
Interaction with the authorities or notified bodies
Assist the investigation and evaluation of regulatory history, guidelines, policies and regulation specific to products and markets
Provide regulatory input to product life cycle process
Assist in the development of regulatory strategy
Actively participate and support required QMS activities

Requirements:
Master Degree in Life Sciences or Engineering
Multiple years of experience in Regulatory Affairs (RA) for the pharmaceutical or medical device industry, ideally in both
Strong knowledge of global regulations
Knowledge of MDR
People management experience is preferred
Fluent level of English

Benefits:
Market rate basic salary
Attractive benefit package
Diverse job activities and opportunity to develop on a strategic level
Join a team with a good atmosphere and who organise after work activities
If this job appeals to you please apply here or send your CV to me, Annelies De Baere, on the NonStop Consulting website or 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 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.