Regulatory Affairs Specialist
1 day ago
Job Title: Principal Regulatory Affairs Specialist
We are seeking an experienced Principal Regulatory Affairs Specialist to play a key role in supporting regulatory strategies and ensuring the success of our diagnostic products in the global market.
Key Responsibilities:
- Regulatory Submissions and Documentation: Prepare and manage regulatory submissions, particularly for FDA 510(k), PMA, and EMA IVDR filings, ensuring technical accuracy and compliance.
- Compliance and Product Development Support: Provide regulatory expertise and guidance to cross-functional teams (engineering, clinical, quality) during product development, ensuring compliance with relevant standards (FDA QSR, ISO 13485, IVDR, ISO 14971).
- Regulatory Strategy and Risk Management: Contribute to regulatory strategy development by collaborating with leadership to identify the most efficient pathways for product approval.
Requirements:
- Experience: 5+ years of experience in regulatory affairs, with a focus on diagnostic devices and proven experience with FDA and EMA Dx submissions (510(k), PMA, IVDR).
- Expertise: Regulatory submissions for in vitro diagnostic devices (IVD), particularly in AI-driven technologies, pathology, and SaMD (Software as a Medical Device).
- Education: Bachelor's degree in engineering, physical, or life sciences (Advanced degree preferred).
What We Offer:
- A dynamic and collaborative work environment.
- Opportunities for professional growth and development.
- A competitive salary and benefits package.
PathAI is an Equal Opportunity Employer: We are committed to creating a diverse and inclusive workplace that reflects the communities we serve. We welcome applications from qualified candidates who are passionate about contributing to our mission to improve patient outcomes with AI-powered pathology.
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