Regulatory Affairs Specialist

3 weeks ago

Wembley Greater London, United Kingdom Medicareplus International Ltd Full time

Job Summary RA Specialist is responsible for ensuring continued compliance of the Quality Management System of the company with the relevant Medical Device Regulations, International Standards, and Customer Requirements and that this is maintained and implemented accordingly.
Responsible for maintaining and supporting the promotion of regulatory affairs and ensuring that overall regulatory compliance of the Company, is maintained.
· The position provides and contributes to regulatory solutions to business requirements and changes to the regulatory landscape.
· The position provides operational regulatory input and guidance to cross functional teams, ensuring compliance to MDD, MDR and other applicable regulatory standards.
· Furthermore, the Regulatory Affairs Specialist is responsible for the completion of regulatory submissions for product registrations and post-market surveillance (PMS) and vigilance in line with the business needs.

Prepare submissions / regulatory compliance documents in line with agreed timeframes
· Frequent contact with external contract manufacturer and suppliers
· To collate data from multiple sources, interpret and produce meaningful management reports with justified balanced recommendations
· To maintain a personal knowledge of the current Quality Management System and regulatory requirements

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