Senior Regulatory Specialist en 4 C Medical Technologies

Description

The Senior Regulatory Specialist plays a key role in ensuring global regulatory compliance for our innovative transcatheter heart valve technologies. This position is responsible for preparing, reviewing, and finalizing technical and regulatory documentation—including test reports, regulatory submissions, and labeling—to support IDE, PMA, and other international filings. The ideal candidate brings strong writing and analytical skills, a solid understanding of medical device regulations, and the ability to translate complex technical information into clear, compliant documentation. Working cross-functionally, this individual helps keep our products and processes aligned with evolving regulatory standards while enabling timely global submissions and approvals.

ESSENTION JOB RESPONSIBILITIES

• Reviews and finalizes engineering test reports and other documentation needed for regulatory submissions. 
• Reviews and approves documentation change requests.
• Maintains ongoing surveillance and analysis of all pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current.
• Conducts reviews of product and manufacturing changes for compliance with applicable regulations.
• Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.
• Reviews device labeling and marketing materials for compliance with FDA submissions and applicable regulations.
• Performs other related duties as assigned.

Requirements

EDUCATION AND EXPERIENCE

• Bachelor’s degree in Engineering with minimum 3 years of scientific and/or regulatory experience. 
• Must have strong experience writing, reviewing, editing, submitting varied types of documentation along with strong verbal communication and ability to effectively communicate at multiple levels. 
• Must have experience developing concise test reports.
• Experience with IDE, PMA, 510(k) applications, CTN, Shonin is preferred

KNOWLEDGE, SKILLS AND ABILITIES

• Advance skills in Microsoft Office Suite (to be able to publish submissions)
• Organizational skills and ability to handle multiple priorities in a fast-paced environment.
• Ability to work independently and take directions from others is required. 
• Attention to detail in the ability to notice small changes and adjust accordingly