Pragmatic ยท 1 day ago
Regulatory Affairs Manager
Greater Boston
Full-time
Hybrid
Mid, Senior Level
$155K/yr - $175K/yrPragmatic is a Medical Device Company focused on Class III technologies, and they are seeking a Regulatory Affairs Manager to support U.S. and international regulatory activities. The role involves leading the preparation and submission of regulatory applications and ensuring compliance throughout various processes while collaborating closely with multiple teams.
Staffing & Recruiting
Hiring Manager
Jay Hine
Responsibilities
Lead the preparation, submission, and maintenance of IDE, PMA, and 510(k) applications
Develop and update EU MDR (2017/745) technical documentation and global regulatory dossiers
Support MDSAP readiness and registrations for markets such as Health Canada, TGA, ANVISA, and PMDA
Ensure regulatory compliance throughout design control, change control, and risk management processes
Serve as a regulatory liaison with the FDA and Notified Bodies, including pre-submission interactions
Contribute to ISO 13485 system improvements, post-market compliance, and inspection readiness
Qualification
Required
Experience preparing and managing submissions for Class II and/or Class III medical devices
Strong understanding of FDA regulations, EU MDR, and MDSAP frameworks
Familiarity with ISO 13485, design control documentation, and clinical study regulatory support
Highly organized, detail-oriented, and comfortable managing multiple priorities in a fast-paced environment
Company
Pragmatic
Pragmatic Certified is designed to guide you through the minefield of Life Sciences Recruitment.
Founded in 2019
2-10 employees
Funding
Current Stage
Early StageLeadership Team
Jay Hine
Partner
Oliver H.
Partner | Clinical Operations | Executive Search
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