Job Description
We are seeking a highly skilled Senior Regulatory Affairs Specialist to lead our regulatory activities and ensure compliance with all relevant regulations. The successful candidate will be responsible for managing the entire lifecycle of products, from product certification and clearance to ongoing maintenance and improvement of our Quality Management System.
The Senior Regulatory Affairs Specialist will work closely with cross-functional teams to prepare regulatory submissions for various markets, coordinate input from stakeholders, track and support product clearances and certifications to completion. Additionally, they will maintain technical files for cleared products, support the Senior Quality & Regulatory Manager in managing product certification testing, and assist with complaints handling for medical reporting and filing to competent authorities.
Key Responsibilities
* Manage regulatory and vigilance processes
* Prepare regulatory submissions for required markets
* Coordinate input from other stakeholders
* Track and support product clearances and certifications to completion
* Maintain technical files for cleared products
* Support Senior Quality & Regulatory Manager in managing product certification testing
* Assist with complaints handling for medical reporting and filing to competent authorities
Requirements
* Third-level degree
* Significant experience in medical devices
* Post-graduate qualification in Quality Assurance (advantageous)
* Regulatory affairs experience, including international regulatory processes
* Knowledge of product certification testing requirements for active Medical Devices
* Knowledge of maintaining a certified Quality Management System
* Experience of EN/MDD/MDR, ISO13485 and FDA requirements
* Trained QMS Internal Auditor
* Strong attention to detail, excellent verbal and written communication skills, results-oriented and self-starter
Skills and Qualifications
* Expert knowledge of regulatory processes for EU, UK, and FDA product clearance
* Working experience of regulatory processes for ROW markets
* Working experience of a certified Quality Management System
* Lean six sigma, TQM knowledge and application
* Advanced Microsoft Office and reporting tool skills
* Strong project management skills