Senior Regulatory Affairs Associate - Global Medical Devices Company - Nuremberg, Germany - €negotiable
The Senior Regulatory Affairs Associate is responsible for developing strategies and securing regulatory approvals, supporting product development initiatives.
This is an exciting time to join an expanding, highly successful global medical devices company based at their site in Cheshire. They develop and manufacture their own products and have an excellent R&D capability ensuring they stay art the forefront of medical devices and associated technology.
* Global, leading medical devices company
* Manufacture and register a range of high-qualitydevices as well as many more in the pipeline
* At the forefront of medical devices, particularly within wound care
The Senior Regulatory Affairs Associate will be responsible for;
* Provide regulatory input to new product developments and major extensions to existing product lines.
* Compile and submit regulatory submissions for approval to regulatory authorities in the EU and US.
* Maintain regulatory files e.g. Technical Files, Design Dossiers, PMA and 510(k).
* Maintain current registrations, licenses, Regulatory Certification, and submissions to ensure compliance with the latest medical devices' regulations.
To apply for this role as a Senior Regulatory Affairs Associate our client is hoping for someone with the following skills and experience;
* Good Regulatory Affairs experience within Medical Devices (ideally 5 years).
* Experience with compiling and submitting EU regulatory submissions (Class IIa, IIb, and III CE submissions) and US FDA 510(k) or PMA submissions is required.
* Working knowledge of European and US medical devices requirements and regulations is required.
* Strong communication and technical writing skills required
* Science based degree
What should you do next?
This Senior Regulatory Affairs Associate role is one not to be missed; it encompasses the opportunity to work with new and exciting products within a company who are at the forefront of medical devices. To discuss further, please submit your current CV.
Unless otherwise stated, if applying for a job within the European Union, you must ensure that you are already authorised to work there.
Carrot Pharma Recruitment Ltd acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.