We are seeking a highly skilled Regulatory Affairs Expert to join our team.
About the Role:
* The Regulatory Affairs Expert will be responsible for managing the regulatory and vigilance process, including preparing regulatory submissions for required markets and maintaining technical files for all cleared products.
* This role requires close coordination with stakeholders to ensure timely product clearances and certification.
* The successful candidate will also support the Quality & Regulatory Manager in managing product certification testing and risk management processes.
Responsibilities:
1. Manage the regulatory and vigilance process.
2. Prepare regulatory submissions for required markets.
3. Maintain technical files for all cleared products.
4. Support the Quality & Regulatory Manager in managing product certification testing.
5. Support the Quality & Regulatory Manager in managing the Risk Management process for all existing and new products.
6. Handle complaints from a medical reporting and filing perspective.
7. Keep up to date with changing regulatory requirements.
8. Maintain environmental registrations for all markets.
9. Support labelling and packaging updates from a regulatory perspective.
10. Complete internal audits as required.
Requirements:
* A third-level degree in a relevant field.
* Significant experience in medical devices.
* Post-graduate qualification in Quality Assurance is an advantage.
* Experience in regulatory affairs, including international processes.
* Knowledge of product certification testing requirements and quality management systems.
* Advanced Microsoft Office skills.
* Strong project management skills.
What We Offer:
A challenging role with opportunities for growth and development in a dynamic industry.
How to Apply:
Please submit your application, including your resume and cover letter, to us. We look forward to hearing from you.