Regulatory Affairs Professional
We are seeking a skilled Regulatory Affairs Specialist to manage regulatory and vigilance processes, prepare regulatory submissions, and maintain technical files.
Key Responsibilities:
* Coordinate regulatory processes and ensure compliance with relevant regulations.
* Prepare and submit regulatory documents for product clearances and certification.
* Maintain accurate and up-to-date technical files for all cleared products.
* Support the Senior Quality Manager in managing product certification testing and risk management.
* Handle complaints and medical reporting, filing with the appropriate authorities.
* Stay informed about changing regulatory requirements and ensure compliance.
* Manage environmental registrations for all markets.
* Contribute to labeling and packaging updates and creations from a regulatory perspective.
* Lead internal audits and support quality team in maintaining the Quality Management System.
Requirements:
* Third-level degree in a related field and significant experience in medical devices.
* Post-graduate qualification in Quality Assurance and experience with active medical devices.
* Proven regulatory affairs experience, including international regulatory processes.
* In-depth knowledge of product certification testing requirements.
* Proficiency in Quality tools and Methodologies.
* Experience with EN/MDD/MDR, ISO13485, and FDA requirements.
* Trained QMS Internal Auditor.
* Strong analytical and problem-solving skills, excellent communication and teamwork abilities.
Benefits:
* Opportunities for career growth and professional development.
* Collaborative and dynamic work environment.
* Competitive compensation package.
For further information, please contact our recruitment team.