The Senior Regulatory Specialist plays a key role in ensuring global regulatory compliance for our innovative transcatheter heart valve technologies. Under general direction, 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 U.S. FDA and EU MDR requirements and related 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

• Review, edit, and finalize engineering test reports and other technical deliverables to support regulatory submissions under FDA, EU MDR, and other global frameworks. 
• Prepare and support U.S. and international regulatory submissions in accordance with applicable medical device regulations and standards.
• Partner with engineering and subject-matter experts to identify and resolve regulatory concerns and provide timely, comprehensive responses to agency inquiries.
• Maintain up-to-date knowledge and surveillance of U.S. and international medical-device regulations to ensure global submission readiness and ongoing compliance.
• Review and approve documentation change requests, product labeling, and marketing materials for alignment with regulatory requirements.
• Assess product and manufacturing changes for regulatory impact and ensure appropriate documentation, notification, or approval pathways are followed.
• Communicate new or revised regulatory requirements to relevant stakeholders and ensure timely implementation.
• Perform other related duties as assigned to support regulatory compliance and organizational objectives.

EDUCATION AND EXPERIENCE

• Bachelor’s degree in Engineering or a related discipline.
• Minimum of three (3) years of experience in regulatory affairs within the medical-device industry.  
•  Experience with U.S. FDA submissions (IDE, PMA, 510(k)) and international pathways (EU MDR, Health Canada MDL, Japan Shonin) preferred.
• 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

• Strong proficiency in authoring, reviewing, and editing technical and regulatory documentation, with excellent written and verbal communication skills across organizational levels.
• Advanced proficiency in Microsoft Office Suite and document-publishing tools used for regulatory submissions.
• Excellent organizational and prioritization skills, with the ability to manage multiple concurrent projects in a fast-paced environment.
• Ability to work independently while collaborating effectively across functions.
• Strong attention to detail and accuracy, with the ability to identify and resolve discrepancies.
• Attention to detail in the ability to notice small changes and adjust accordingly.
• Able to travel up to 10%.