A Regulatory Affairs Specialist is required by CareerWise Recruitment for our Galway based client.
The job requires the person to work within the current regulatory environment and frameworks for all relevant markets to market products and to ensure in conjunction with the commercial requirements that all regulatory requirements for the individual markets are met.
Role of this position
- Define regulatory strategy for individual devices within the Product Development Process.
- Manage Regulatory Assessment of any Device / Quality System changes, and any subsequent notifications that are required to be made to Regulatory Agencies.
- Ensure country specific registration activities are understood and appropriately addressed.
- Participate in Notified Body / Regulatory Agency audit preparation and follow up.
- Identify and initiate required action(s) to address any adverse trends or regulatory compliance issues.
- A minimum of a diploma in a Quality/Regulatory or related discipline, and at least 3 years practical and relevant experience in Regulatory Affairs, medical device preferable.
- Good understanding of ISO 13485 and FDA QSR quality standards.
- Possess strong Technical Writing ability.
- Have a methodical review approach and be capable of initiating and leading change and continuous improvement.
Please call Lisa Casserly today for further information on 091-339136 or email: email@example.com
CareerWise Recruitment (In Search of Excellence)