Job Description
Our client seeks a Senior Regulatory Affairs Specialist to support the ongoing maintenance, audit and continuous improvement of specific elements of the Quality Management System.
The successful candidate will be responsible for all regulatory activities including product certification and compliance, managing the regulatory and vigilance process, preparing regulatory submissions for required markets, and coordinating input from other stakeholders.
Maintaining technical files for all cleared products, supporting the Senior Quality & Regulatory Manager in managing any required product certification testing, and complaints handling for medical reporting and filing to the appropriate competent authorities are also key responsibilities.
Additionally, the Senior Regulatory Affairs Specialist will need to maintain environmental registrations for all markets, support labelling and packaging updates and creations from a regulatory and clinical claims perspective, and complete internal audits as required and lead CE technical file audits for the company.
Required Skills and Qualifications
* A third level degree in a relevant field such as quality assurance or regulatory affairs.
* Significant experience in medical devices, with a post-graduate qualification in Quality Assurance being an advantage.
* Regulatory affairs experience including knowledge of international regulatory processes is essential.
* Expertise in maintaining a certified Quality Management System and application of Quality tools and Methodologies including lean six sigma, TQM etc.
* Knowledge and application of Quality standards including EN/MDD/MDR, ISO13485 and FDA requirements.
Benefits
As a Senior Regulatory Affairs Specialist, you will have the opportunity to work on challenging projects and contribute to the development of the Quality Management System.
You will be working closely with a team of experienced professionals who share your passion for quality and regulatory compliance.
Excellent verbal and written communication skills, results orientated, and self-starter with the ability to work on own initiative are essential qualities for this role.
Others
This role is perfect for someone who wants to develop their skills in regulatory affairs and quality management. You will have opportunities to learn and grow with our organisation.