Job Description

Regulatory Affairs Specialist - Principal Specialist

I am partnered with a rapidly growing, science-driven medical device company focused on developing transformative therapies for cardiovascular disease. This innovative company is advancing a new class of technology designed to mimic native valve performance, with global offices and an inclusive, mission-driven team dedicated to improving patient lives through innovation.

Reporting to the Director of Regulatory Affairs, the Regulatory Affairs Specialist will lead and execute regulatory submission and approval activities, primarily focused on U.S. FDA submissions (e.g., 510(k), PMA, IDE), while also supporting global regulatory initiatives. This individual will serve as a key liaison with regulatory agencies and provide critical support for clinical study activities, ensuring compliance and enabling timely market access.

This is a high-impact role offering the opportunity to shape regulatory strategies for a next-generation Class III cardiovascular device. The position may be tailored to the appropriate seniority level (e.g., Senior or Principal) based on experience.

Key Responsibilities

• Lead regulatory planning and execution for U.S. and international submissions
• Prepare and review FDA submissions, including IDEs, 510(k)s, PMAs, and supplements
• Serve as the regulatory representative on cross-functional project teams
• Act as a liaison with the FDA and global regulatory agencies
• Support regulatory aspects of clinical studies and related documentation
• Review and approve documents to ensure regulatory compliance
• Maintain certificates, licenses, and global product registrations
• Support audits and quality system maintenance

Qualifications

• Bachelor’s degree in science or engineering (advanced degree a plus)
• 5+ years of regulatory affairs experience, including U.S. submissions
• Class III medical device experience required
• Cardiovascular experience strongly preferred
• Working knowledge of global regulatory requirements and quality standards (FDA, EU MDR, ISO 13485)
• Strong project management, communication, and problem-solving skills

RAC certification preferred

*Please note that we are unable to provide sponsorship for this role

Apply today or reach out directly to [email protected]

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