Who We Are
Regulatory Affairs Management Consultants, focused FDA approval for medical devices and IVDs - we pride ourselves on having a strong, distinctive and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose.
About The RoleThe Regulatory Affairs Intern position will work closely with the Regulatory Team to provides support for activities and health authority submissions while adhering to company standards and complying with health authority regulations and guidance.
Key Skills&Experience Desired (ideal candidate)
- Effective writing and oral communication skills
- Strong analytic skills
- Experience conducting policy research and analysis, including federal laws and regulations
- Willing to take initiative to learn new things and work on multiple projects at once
- Team player who works collaboratively, responds to feedback, and proposes solutions
- Experience with, knowledge of, and interest in quality improvement and long-term care a plus
- Proficiency in Microsoft Office programs
YOUR CONTRIBUTIONS (include, But Are Not Limited To)
- Perform analysis of regulations and policies impacting medical products
- Understanding and implementing requirements and programs that impact regulatory approval and compliance
- Track quality and regulatory issues and develop summaries or updates for members
- Identify and assess trends in enforcement and oversight of medical products
- Support development of responses to client and prospect questions and requests for assistance
- Review and comment on proposed federal regulations, policies or guidance
- Collaborate with staff, cross functional teams and workgroups including Regulatory and Quality Improvement teams
- Support the creation and update of product-specific global regulatory development plans.
- Support the preparation of
submissions to regulatory authorities.
- Support development of regulatory processes for new and changing company initiatives and healthy authority regulations.
- Maintain submission and correspondence logs
- Other projects as assigned from Quality and Regulatory Department
Interested candidates should submit resume, cover letter and 2 writing samples in reply to our job posting on LinkedIn (preferred) or contact Tony@Zi-Medical.com.