Regulatory Affairs Specialist

About This Role

This specialist role drives global regulatory compliance and product submissions for cutting-edge medical devices across domestic and international markets. The position involves collaborating with cross-functional teams to ensure compliance with various regulations and coordinating submissions for product approvals.

Responsibilities

• Partner with Quality, Engineering, Operations, and Document Control to ensure business compliance with FDA Quality System Regulation (21 CFR Part 820), ISO 13485, EU MDR, MDSAP, and applicable international regulations
• Coordinate the preparation, assembly, and submission of 510(k)s, Technical Files, Letters to File, Product Registrations, and international market registrations to obtain approvals for product development, clinical trials, and marketing authorizations
• Prepare, review, and submit regulatory documents
• Maintain up-to-date regulatory files
• Conduct internal audits and support customer and regulatory agency audits as needed
• Stay abreast of evolving global regulatory requirements
• Provide regulatory guidance to project teams
• Facilitate communication between internal stakeholders, notified bodies, and regulatory authorities
• Offer support in Quality Management System (QMS) operations, including surveillance, reporting, and label approvals as necessitated

Requirements

• Bachelor’s degree in a science or engineering field (such as biology, chemistry, or pharmacy)
• 3 to 5 years of working experience in a regulated field like clinical research or medical manufacturing
• Experience working with international manufacturing locations
• Direct working experience with FDA regulations, EU MDR, and MDSAP
• Bilingual fluency in both English and Spanish (written and verbal)

Nice to have:

• Advanced degree in a related science or engineering field
• Experience with Class II and/or Class III medical devices
• Experience supporting manufacturing operations in Latin America
• Regulatory Affairs Certification (RAC) and/or Regulatory Affairs Professionals Society (RAPS) membership

Benefits

• Purpose-driven work: Directly contribute to the approval and delivery of life-changing medical technologies
• Innovative projects: Engage with complex global markets, EU MDR initiatives, and class-leading medical devices
• Collaborative culture: Work side-by-side with cross-functional teams spanning quality, engineering, and international operations
• Career growth: Expand your regulatory expertise across multiple global jurisdictions and regulatory frameworks
• Competitive benefits: Enjoy a comprehensive total rewards package designed to support you and your family