Regulatory Affairs Specialist with at least 3 years experience in a highly regulated environment such as medical devices required by growing R&D site in Galway city. Reporting to the Section Leader you will ensure that all regulatory responsibilities are carried out efficiently.
- Define regulatory strategy for individual devices within the product development process.
- Manage CE mark submissions and notified body interactions.
- Assist with the preparation of 510(k) regulatory filings and FDA correspondence.
- Manage regulatory assessment of any device or quality system changes.
- Ensure country specific registration activities are understood and addressed.
- Participate in audit preparation.
- Identify required action to address any regulatory compliance issues.
- BSc. in Quality/Regulatory or related discipline
- 3+ years relevant experience in Regulatory Affairs
- Strong technical writing ability
- Methodical review approach, and can lead continuous improvement
- Ability to work within a team environment
- Understanding of ISO 13485 and FDA QSR quality standards
Please contact Emer Moore to discuss in confidence