Job summary
Job post source
This job is directly from Katalyst CRO
Job overview
The Regulatory Affairs Specialist-II at Katalyst CRO leads regulatory strategies and submissions for medical device products, focusing on software as a medical device and AI technologies to ensure compliance and market approval.
Responsibilities and impact
The role involves developing regulatory strategies, reviewing design documentation, preparing and submitting regulatory filings, liaising globally on regulatory matters, providing guidance on software and cybersecurity compliance, supporting audits, and collaborating with cross-functional teams to ensure regulatory compliance and successful product lifecycle management.
Experience and skills
Candidates need a bachelor's degree in Engineering, Biology, or Regulatory Science with 3+ years of experience, proven expertise in software as a medical device regulations, FDA digital health guidance, 510(k)/De Novo submissions, familiarity with IEC 62304, ISO 13485, EU MDR, cybersecurity requirements, RAC certification, and strong communication and leadership skills.
Job location and travel
The position requires less than 15% overnight travel, potentially domestic or international, but specific location details are not provided.
Unique job features
The job uniquely focuses on regulatory aspects of AI, machine learning, and connected orthopedic wearable devices, requiring specialized knowledge in digital health regulations and cybersecurity.
Company overview
Katalyst CRO is a contract research organization specializing in providing comprehensive clinical trial management and support services to pharmaceutical, biotechnology, and medical device companies. They generate revenue by offering tailored solutions in clinical operations, regulatory affairs, data management, and biostatistics to accelerate drug and device development processes. Founded with a focus on innovation and efficiency, Katalyst CRO emphasizes collaboration and cutting-edge technology to deliver high-quality results. Their expertise spans multiple therapeutic areas, making them a trusted partner in advancing healthcare solutions globally.
How to land this job
Position your resume to showcase your expertise in regulatory strategy development, especially for SaMD, AI, and connected orthopedic devices, emphasizing your experience with FDA 510(k) and De Novo submissions.
Highlight your knowledge of global regulatory standards such as FDA guidance on digital health, EU MDR, IEC 62304, and cybersecurity compliance, and your ability to collaborate cross-functionally with engineering, clinical, and marketing teams.
Apply through multiple channels including the Katalyst CRO corporate careers page and LinkedIn to maximize your application visibility and ensure you meet their preferred candidate sourcing methods.
Connect with professionals in Katalyst CRO's regulatory affairs or product teams on LinkedIn; use ice breakers like commenting on recent regulatory challenges in digital health or asking about their approach to global regulatory harmonization.
Optimize your resume for ATS by incorporating keywords from the job description such as 'regulatory strategy', 'SaMD', 'FDA 510(k)', 'De Novo', 'cybersecurity', 'EU MDR', and 'post-market compliance' to ensure it passes automated screening tools.
Leverage Jennie Johnson's Power Apply feature to automate tailored applications across multiple platforms, identify relevant LinkedIn contacts for networking, and optimize your resume for ATS, allowing you to focus on interview preparation and skill enhancement.
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