Regulatory Affairs Specialist – Galway
Excellent opportunity to join a market-leading medical device company. 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 / significant changes and notified body interactions.
- Assist with the preparation of 510(k) regulatory filings and subsequent FDA correspondence on submissions.
- Manage regulatoryassessment of any changes.
- Ensure country specific registration activities are understood.
- Participate in audit preparation and follow up.
- Identify and initiate required action to address any adverse trends or regulatory compliance issues.
- Diploma in a Quality/Regulatory or related discipline
- 3+ years experience in Regulatory Affairs, medical device preferable.
- Abilitiy to work independently in a timely manner.
- Possess strong technical writing ability.
- Have a methodical review approach.
- Ability to work within a team environment.
- Good understanding of ISO 13485 and FDA QSR quality standards.
- Must be authorised to work in Ireland.
Please contact Mary-Ann Keena to learn more
+353 (0) 83 0220666