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Details

Regulatory Affairs Project Lead


Reference:SMC8054 Location: Cork
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Project Lead

We’re currently recruiting for an exciting opportunity with an award-winning Medical Device organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

• Directs and coordinates activities concerned with the submission and approval products to government regulatory agencies.
• Provides guidance to project team members regarding regulatory compliance issues.
• Oversees the preparation and maintenance of regulatory submissions and files.
• Establishes accountability for the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
• Ensures adherence to standard operating procedures and protocol for the rapid and timely approval of new products and regulatory support of marketed products.
• Interacts with regulatory agency personnel in order to expedite approval of pending application and to resolve regulatory matters.
• Consults with management personnel to establish and prepare appropriate regulatory filings for product approvals.
• Works with team members to determine regulatory impact of manufacturing changes on products, prepare and submit applications, and the assess the impact product changes have on the status of regulatory licenses.
• Interprets regulatory requirements and determines strategies to obtain clearances and approvals
• Independently makes decisions regarding work processes or operational plans and schedules


Education & Experience

• Masters or equivalent preferred.
• Regulated industry experience is required. Previous experience with medical devices is strongly preferred.
• Demonstrated track record of developing and executing global regulatory strategies that align with business deliverables is required.
• Experience working with professional and trade associations is a plus.


If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or [email protected] for further information.