Senior Regulatory Affairs Specialist Job Summary
This role involves overseeing all regulatory activities, including product certification and compliance, as well as supporting the ongoing maintenance, audit and continuous improvement of specific elements of the Quality Management System.
* Regulatory Process Management:
* The successful candidate will be responsible for managing the regulatory and vigilance process, preparing regulatory submissions for required markets, coordinating input from other stakeholders, tracking and supporting product clearances and certification to completion.
* Technical File Maintenance:
* Maintaining technical files for all cleared products is a key responsibility of this position.
* Support to Senior Quality & Regulatory Manager:
* The Senior Regulatory Affairs Specialist will support the Senior Quality & Regulatory Manager in managing any required product certification testing and the Risk Management process for all existing and new products.
* Medical Reporting and Filing:
* Complaints handling for medical reporting and filing to the appropriate competent authorities is another important task.
* Regulatory Updates and Registrations:
* The successful candidate will be responsible for keeping up to date with changing regulatory and compliance requirements and maintaining environmental registrations for all markets.
* Labelling and Packaging Updates:
* Supporting labelling and packaging updates and creations from a regulatory and clinical claims perspective is also part of this role.
* Audit and Compliance:
* Complete internal audits as required and lead CE technical file audits for the company.
* Quality Management System (QMS) Support:
* The Senior Regulatory Affairs Specialist will support the Quality team in maintaining the QMS.
Key Skills and Qualifications
The ideal candidate will possess expert knowledge of regulatory processes for EU, UK and FDA product clearance, as well as working experience of regulatory processes for ROW markets and a certified Quality Management System.
About This Role
This is an excellent opportunity for a professional seeking a challenging and rewarding role in regulatory affairs. The successful candidate will have the opportunity to work with a variety of stakeholders, including cross-functional teams and external partners.