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Medline makes #healthcare run better
Senior Regulatory Affairs Specialist
Location
Illinois
Posted
93 days ago
Salary
$92K - $138K / year
Seniority
Senior
Job Description
Senior Regulatory Affairs Specialist
Medline Industries, LP
• 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
Job 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
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