Regulatory Affairs Specialist
Galway Municipal District - This Area Only
The job requires the person to work within the current regulatory environment and frameworks for all relevant markets that Aerogen wishes to market our products and to ensure in conjunction with the commercial requirements that all regulatory requirements for the individual markets are met and this involves a varied set of duties and responsibilities.
In the absence of the Section Leader Regulatory Affairs, the Regulatory Specialist will report to the QA/RA Director.
• In conjunction with Section Leader Regulatory Affairs, define regulatory strategy for individual devices within the Product Development Process.
• As appropriate, 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 Regulatory Assessment of any Device / Quality System changes, and any subsequent notifications that are required to be made to Regulatory Agencies.
• Work with the Commercial Team / Aerogen Distributors, to ensure country specific registration activities are understood and appropriately addressed.
• Participate in Notified Body / Regulatory Agency audit preparation and follow up.
• In conjunction with the Section Leader Regulatory Affairs and in a timely manner; identify and initiate required action(s) to address any adverse trends or regulatory compliance issues.
• In order to coordinate the variety of regulatory related tasks, the role requires a high degree of flexibility, and structured time and task management.
• 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.
• Excellent verbal and written communication skills.
• Excellent attention to detail skills.
• The person must be a self-starter in terms of time and task management, and be able to operate with minimal supervision.
• Possess strong Technical Writing ability.
• Have a methodical review approach, and be capable of initiating and leading change and continuous improvement.
• Ability to work within a team environment to achieve agreed company goals.
• Good understanding of ISO 13485 and FDA QSR quality standards.
Typical office environments, with work also performed in R&D and manufacturing labs, and customer/supplier locations.
At least 3 years practical and relevant experience in Regulatory Affairs, medical device preferable.
Posted 19 days ago