Regulatory Affairs Specialist
4 weeks ago
Regulatory Affairs Specialist Role
PathAI is seeking an experienced Regulatory Affairs Specialist to support the development and approval of our diagnostic products. As a key member of our regulatory team, you will work closely with cross-functional teams to ensure compliance with regulatory requirements and guidelines.
Key Responsibilities:
- Prepare and manage regulatory submissions, including FDA 510(k), PMA, and EMA IVDR filings.
- Organize technical files, design dossiers, and regulatory documentation for diagnostic products.
- File pre-submission requests and respond to inquiries from global regulatory bodies.
- Author/write regulatory documents in support of our submission process.
Requirements:
- 5+ years of experience in regulatory affairs, with a focus on diagnostic devices and proven experience with FDA and EMA Dx submissions.
- Expertise in regulatory submissions for in vitro diagnostic devices (IVD), particularly in AI-driven technologies, pathology, and SaMD (Software as a Medical Device).
- Demonstrated hands-on experience in leading regulatory filings and bringing products to market globally.
What We Offer:
At PathAI, we are committed to creating a workplace that is free of harassment and discrimination. We base our employment decisions on business needs, job requirements, and qualifications. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.
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