An exciting new position has become available for a Senior Regulatory Affairs Specialist to join a large organisation based in Medway.

Duties include;

* Develop Regulatory strategy for private labelled medical device/products for compliance meeting applicable country guidelines. Managing product changes and compliance in line with business priorities and regulatory requirements.
* Manage stakeholder needs for new product introduction, certification and registration in new and existing markets. Working closely with EU Centre of Regulatory Excellence, Corporate Brand and Global Supply Chain to provide regulatory information and documentation to support product supply.
* Provide guidance and leadership for global filings supporting the growth of the regulatory departments.
* Technical file and Compilation maintenance; filing applications for market entry and handling all regulatory government interactions.
* Conducting device and cosmetic registration for UK business support and EU labelling worldwide.
* Implementing necessary pathways, exporting criteria for individual countries and collate and provide documentation for market entry.
* Managing regulatory changes effecting domestic and global distribution of private label products.
* Representing the regulatory affairs on projects for new business and ongoing compliance for Optident product.
* Managing processes for private label creation, launching and supporting operational product supply.
* Communicating with external and internal suppliers/ manufacturers working alongside to ensure their services meet the company SLAs.
* Ensure the organisation is compliant with the relevant certificates and authorisation to produce, sale and distribute goods.
* Implementing QMS processes and maintaining QS and product certification.
* Building a good rapport with government agencies, representing the organisation and being proactive with legislative or industry standards.
* Risk assessing, conducting inspections of the organisation and its suppliers taking part in any due diligence, targets and inspections.
* Striving for continuous improvement of systems and processes within the quality department, including internal training for cross functional departments.

The successful candidate will be/ have;

* Minimum 4 years of regulatory Affairs and Quality system experience in the medical device industry.
* Able to manage and comply within ISO 9001 and ISO 13485 quality management system.
* Compile and Maintain EU Technical Files and documentation.
* Confident in communicating with Regulatory Bodies and hosting compliance inspections.
* Proactive in effectively managing staff, processes, and technology.
* A tertiary degree preferably in a scientific/technical or medical related field.
* Must be fluent in written and spoken English demonstrating excellent communication skills.



This is a fantastic opportunity to join a large, successful organisation who offer great benefits, a good working culture and the opportunity to progress.

If you feel you meet the above criteria and are ready for a new challenge then please apply online for immediate consideration.

This role is being handled by Nicole Hill, Business Support Consultant for Pearson Whiffin Recruitment.