Senior Regulatory Affairs Specialist

Role Overview

• Responsible for planning and executing critical and complex global regulatory projects necessary to obtain and maintain global regulatory approvals
• Prepare comprehensive regulatory strategies for new devices, new launch markets, and post-market device changes
• Determine the requirements for completing and maintaining product submissions and regulatory filings
• Communicate requirements of regulations to internal or external customers
• Review and provide direction to ensure supporting evidence meets appropriate regulatory requirements
• Complete and maintain varied regulatory filings by leading internal groups and collaborating with external groups
• Assist in the review and development of processes related to regulatory activities of responsibility
• Actively participate in internal and external audits when applicable

Requirements

• B.A. or B.S. degree in life science field (biology, microbiology, chemistry, etc.), engineering, medical technology, regulatory science, or related
• At least 4 years of experience in regulatory affairs in the medical device industry supporting domestic or international markets
• Experience authoring and submitting regulatory submissions including 510(k)s and/or CE Technical Files
• Experience preparing responses and communicating with regulatory agencies
• Applied knowledge of FDA regulations and guidelines
• Ability to evaluate information to determine compliance with standards, laws, and regulations
• Position requires up to 10% travel

Benefits

• health insurance
• life and disability
• 401(k) contributions
• paid time off
• access to Employee Assistance Program
• access to Employee Resource Groups
• access to Employee Service Corp