Senior Regulatory Affairs Specialist
We are seeking a Senior Regulatory Affairs Specialist to join our client, a growing medical device organization.
Key Responsibilities:
* Manage regulatory and vigilance processes.
* Prepare regulatory submissions for required markets, coordinating input from other stakeholders and tracking product clearances and certification to completion.
* Maintain technical files for all cleared products.
* Support the Senior Quality & Regulatory Manager in managing product certification testing and the Risk Management process for all existing and new products.
* Handle complaints, including medical reporting and filing with competent authorities.
* Stay up-to-date with changing regulatory and compliance requirements, such as REACH and ROHS2.
* Maintain environmental registrations for all markets.
* Support labelling and packaging updates and creations from a regulatory and clinical claims perspective.
* Complete internal audits as required and lead CE technical file audits for the company.
Requirements:
* A third-level degree and significant experience in medical devices.
* A post-graduate qualification in Quality Assurance is an advantage, along with experience of active medical devices.
* Significant regulatory affairs experience, including international regulatory processes.
* In-depth knowledge of product certification testing requirements for active Medical Devices.
* In-depth knowledge of maintaining a certified Quality Management System.
* Knowledge and application of Quality tools and methodologies, including Lean Six Sigma and TQM.
* Experience of EN/MDD/MDR, ISO13485, and FDA requirements.
* A trained QMS Internal Auditor.
* Strong attention to detail and excellent verbal and written communication skills.
* Results-oriented and a self-starter, able to work on own initiative.
* Knowledge of and commitment to continuous improvement and problem solving.
* Promote best practice and knowledge of the QSR and ISO/MDD standards.
* Advanced Microsoft Office and reporting tool skills.
* Strong project management skills.
Salary:
$95,000 - $115,000 per year, depending on experience.