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Details

Regulatory Affairs Specialist


Reference:KG-ARVS-733434 Location: Galway
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed

This job requires the person to work within the current regulatory environment and frameworks for all relevant markets. You will support marketing the products and ensure they are in conjunction with the commercial requirements.

Duties/Responsibilities:
• Define regulatory strategy for individual devices within the Product Development Process.
• As appropriate, manage Submissions and Significant Changes and Notified Body interactions.
• Assist with the preparation of egulatory filings and subsequent FDA correspondence on submissions.
• Manage Regulatory Assessment of any Device and Quality System changes, and any subsequent notifications that are required to be made to Regulatory Agencies.
• Work with the Commercial Team and Distributors, to ensure country specific registration activities are understood and appropriately addressed.
• Participate in Notified Body, and Regulatory Agency audit preparation.

Education/Experience:
• A minimum of a Degree (Hons) in Quality/Regulatory or related discipline
• 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.
•Good understanding of ISO and FDA quality standards.

Environmental Conditions:
• Typical office environments, with work also performed in R&D and manufacturing labs, and customer/supplier locations.

If you would like further Information you can contact the recruiter directly:

Kevin Silke | Tel: +353 (0) 1 507 9255