Description
The Regulatory Affairs Specialist is responsible for the implementation of international regulatory strategies, priorities agreed among EEMEA Marketing and country management;Main Responsibilities;
- Define RA submission plan based on marketing and sales expectations
- Communicate to divisions RA submission plan, registration priorities, time frames and regulatory requirements
- Place request in the system to obtain product registration dossiers from Divisions, tailor them to meet country registration requirements
- Pull out documents from documentation system
- Support Local RA/QA groups in EEMEA for local product submission and getting support from divisions
- Create, evaluate or update RA related policies and procedures to ensure regulatory compliance maintenance
- Review and evaluate impact of product changes on registrations or product supply
- Assist divisions in determining appropriate product testing to support International registrations, for products in R&D phase
- Review and provide input on regulatory aspects related to distribution agreements
Necessary Experience;
- At least 1-2 years experience in a international organizational business environment.
- Must have experience of international Medical Device Registrations
- Prior experience of product registration of Medical device in Europe and EEMEA .
- Any experience in a MD area (also operational environment, good understanding of MD Business and processes).
- Good understanding European and US FDA regulations and international standards applicable to medical devices industry.
If you believe you have the correct experience then please send me your CV and I will be in touch shortly