Senior Regulatory Affairs Specialist
We are seeking a highly experienced Senior Regulatory Affairs Specialist to join our client, a growing medical device organization.
The successful candidate will be responsible for 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.
Key Responsibilities:
* Manage the regulatory and vigilance process.
* Prepare regulatory submissions for required markets, coordinating input from other stakeholders, tracking, and supporting product clearances and certification to completion.
* Maintain technical files for all cleared products.
* Support the Senior Quality & Regulatory Manager in managing any required product certification testing.
* Support the Senior Quality & Regulatory Manager in managing the Risk Management process for all existing and new products.
* Handle complaints related to medical reporting and filing with the appropriate competent authorities.
* Stay up-to-date with changing regulatory and compliance requirements, such as REACH and ROHS2.
* Maintain environmental registrations for all markets.
* Support labeling 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.
* Support the Quality team in maintaining the QMS.
* Have expert knowledge of regulatory processes for EU, UK, and FDA product clearance.
* Have working experience of regulatory processes for ROW markets.
* Have working experience of a certified Quality Management System.
Requirements:
* You will have a third-level degree and significant experience in medical devices.
* A post-graduate qualification in Quality Assurance, along with experience in active medical devices, would be an advantage.
* You will have significant regulatory affairs experience, including experience of international regulatory processes.
* You will have in-depth knowledge of product certification testing requirements for active Medical Devices.
* You will have in-depth knowledge of maintaining a certified Quality Management System.
* You will have knowledge and application of Quality tools and methodologies, including Lean Six Sigma and TQM.
* You will have experience of EN/MDD/MDR, ISO 13485, and FDA requirements.
* You will be a trained QMS Internal Auditor.
* You will have strong attention to detail.
* You will have excellent verbal and written communication skills.
* You will be results-oriented and a self-starter with the ability to work on your own initiative.
* You will have knowledge of and commitment to continuous improvement and problem-solving.
* You will promote best practice and knowledge of the QSR and ISO/MDD standards.
* You will have advanced Microsoft Office and reporting tool skills.
* You will have strong project management skills.