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
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