Compliance and Risk Manager overseeing government compliance programs within aerospace and defense environments. Responsible for risk management and ensuring adherence to regulatory requirements across multiple locations.
About the role
- Senior Regulatory Specialist planning and executing complex global regulatory projects for Medline Industries. Preparing regulatory strategies, ensuring compliance, and managing project timelines across multifunctional teams.
Responsibilities
- Responsible for planning and executing critical and complex global regulatory projects
- Prepare comprehensive regulatory strategies for new devices and markets
- Communicate requirements of regulations to internal or external customers
- Review and provide directions to ensure supporting evidence meets regulatory requirements
- Lead internal groups and collaborate with external groups on regulatory filings
- Manage individual projects defining timelines and recommending actions
- Assist in the review and development of processes related to regulatory activities
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
- Experience authoring and submitting regulatory submissions including 510(k)s and/or CE Technical Files
- Experience in preparing responses and communicating with regulatory agencies
- Understanding of the current Regulatory environment
- Applied knowledge of FDA regulations and guidelines
- Position requires up to 10% travel
Benefits
- Health insurance
- Life and disability insurance
- 401(k) contributions
- Paid time off
- Continuing education & training
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