Regulatory Affairs Specialist
Define regulatory strategy for products within the Product Development Process.
Manage CE mark Submissions / Significant Changes and Notified Body interactions.
Assist with the preparation of 510(k) regulatory filings
Manage Regulatory Assessment of any product / Quality System changes, and any subsequent notifications that are required to be made to Regulatory Agencies.
Work with the Commercial Team / Distributors
Audit preparation and follow up.
Identify and initiate required action(s) to address any adverse trends or regulatory compliance issues.
A minimum of a Degree (Hons) in Quality/Regulatory or related discipline, and at least 3 years practical and relevant experience in Regulatory Affairs, medical device preferable.
Excellent verbal and written communication skills.
Excellent attention to detail skills.
Self-starter in terms of time and task management
Strong Technical Writing ability.
Good understanding of ISO 13485 and FDA QSR quality standards.
For more information regarding this role contact Brenda Flannery on 091 507 521 or email Brenda.firstname.lastname@example.org. Visit www.cpljobs.ie for more of our open roles.