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 xcfaprz 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

Desired Skills and Experience

Regulatory Affairs, Orthopedics, 510k, FDA, MDR, Regulatory Submissions, Regulatory Intelligence, Class I, Class IIa, Class IIb, Class III