Sr. RA Specialist

A key client of EPM Scientific is seeking a Sr. Regulatory Affairs Specialist to join their team on a 12 month contract, supporting primarily around Regulatory Submissions & Intelligence in their Joint Replacement Orthopaedics division.

This is a full time role, ASAP start, hybrid on site in Southern Ireland (negotiable).

• Assesses Regulatory Intelligence to assist in the development regulatory strategies
• Evaluates the regulatory environment and provides internal advice throughout the product lifecycle
• Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions
• Evaluates proposed products for regulatory classification and jurisdiction
• Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
• Compares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes
• Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation
• Provides regulatory input and technical guidance on global regulatory requirements to product development teams
• Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations and assesses their acceptability
• Provides regulatory information and guidance for proposed product claims/labeling
• Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines
• Monitors the progress of the regulatory authority review process through appropriate communications with the agency
• Communicates and interacts with regulatory authorities throughout product life cycle and submissions