Senior Regulatory Affairs Specialist
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Job Description
Senior Regulatory Specialist responsible for planning and executing regulatory projects for medical devices at Medline. Ensuring compliance with FDA regulations and managing product submissions.
Responsibilities:
- Responsible for planning and executing 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
- Identify factors that could impact the success or viability of new product launch in assigned market(s)
- Monitor changes in regulations that impact current or future requirements and overall compliance
- 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, collaborating with external groups
- Manage individual projects by providing direction on diverse regulatory pathways
- 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 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
- Understanding of the current Regulatory environment and ability to perform within
- Applied knowledge of FDA regulations and guidelines
- Ability to evaluate information to determine compliance with standards, laws, and regulations
Benefits:
- health insurance
- life and disability
- 401(k) contributions
- paid time off
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