Pragmatic · 1 week ago
Regulatory Affairs Specialist
Massachusetts, United States
Full-time
Hybrid
Entry, Mid Level
$80K/yr - $110K/yr
1+ years expPragmatic is a privately held, venture-backed medical device company based in Bedford, MA, expanding its Regulatory Affairs team following FDA approval of its lead product. The Regulatory Specialist will support U.S. and EU regulatory activities across the product lifecycle, focusing on submissions, technical documentation, and cross-functional product development.
Staffing & Recruiting
Hiring Manager
Jay Hine
Responsibilities
Supporting U.S. regulatory submissions (510(k), IDE, PMA support activities)
Developing and maintaining EU MDR Technical Documentation
Maintaining device registrations and listings
Assessing complaint reportability and preparing adverse event reports
Reviewing engineering change orders and assessing regulatory impact
Supporting standards compliance and regulatory surveillance activities
Acting as a regulatory representative on cross-functional product teams
Supporting QMS maintenance and internal / supplier audits
Maintaining accurate regulatory files and documentation
This is a hands-on regulatory role , not a purely administrative position
Qualification
Required
Bachelor's degree in a scientific or engineering discipline (biology, chemistry, biomedical engineering, etc.)
1–3+ years of Regulatory Affairs experience in medical devices
Hands-on exposure to FDA and/or EU regulatory submissions
Working knowledge of FDA regulations and/or EU MDR
Strong technical writing and documentation skills
Comfortable working cross-functionally with engineering and quality teams
Detail-oriented, organized, and willing to speak up when something doesn't look right
Preferred
Experience with EU MDR Technical Documentation
Exposure to 510(k), IDE, or PMA submissions
RAC certification or interest in pursuing it
Company
Pragmatic
Pragmatic Certified is designed to guide you through the minefield of Life Sciences Recruitment.
2-10 employees
Funding
Current Stage
Early StageLeadership Team
Jay Hine
Partner
Oliver H.
Partner | Clinical Operations | Executive Search
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