Regulatory Affairs Specialist
$42,000–$71,000 year
On-siteCork, Munster, Ireland
Job Summary
Conduct global regulatory strategy development and author premarket applications to secure US and EU approvals for medical devices. Evaluate proposed device changes, review labeling and marketing materials for compliance, and interface directly with FDA, Notified Body reviewers, and other regulatory agencies. Participate in New Product Development Teams to incorporate international requirements and manage submission documentation for expedited market access. Assess quality, preclinical, and clinical documentation for submissions, support product notifications, and provide regulatory input for inspections and audits. Prepare product registrations, maintain regulatory information systems, and assist in process improvement projects while ensuring ongoing compliance for new and existing products.
Required Qualifications
- Bachelor's degree in an Engineering, Science, or equivalent field
- 1-2 years in a Regulatory Affairs role
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