- Support the creation & maintenance of product design and technical documentation in compliance with the relevant regulations and standards.
- Support the development and submission of high-quality regulatory files to the relevant ethical committees and regulatory agencies, ensuring successful approval.
- Organise and maintain regulatory submissions with regulatory authorities.
- Co-ordinate and, where appropriate, conduct gap assessment activities in line with updated regulatory requirements and standards.
- Keep up to date with changes in applicable regulatory requirements and standards.
- Assist company preparation for inspection by a notified body and regulatory authorities.
- Co-ordinate and progress Adverse Event reporting to regulatory authorities.
- Ensuring adherence to all organisational and external regulatory requirements.
- Level 8 or 9 degree in Science or related disciplines.
- Minimum of two (2) years of related experience in Regulatory Affairs, Quality or Design Assurance an advantage.
- Experience of preparing technical documentation for submission to regulatory agencies.
- Class III medical device experience is preferred.
- Working knowledge of GMP, FDA QSR and ISO 13485 requirements.
- Excellent communication, organisational and time management skills.
Or call Megan Warr on 091507515 for a confidential conversation