Regulatory Affairs Specialist

About the Role

As a Regulatory Affairs Specialist, you’ll play a pivotal role in driving global regulatory compliance and product submissions, collaborating with cross-functional teams to deliver cutting-edge solutions in medical device regulatory affairs across domestic and international markets.

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, and 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).

Preferred Qualifications

• 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.

Success Measures

Within the first 12 months, the successful candidate will:

• Significantly progress EU MDR submissions.
• Identify post-submission continuous improvement actions.
• Maintain successful FDA, ISO, and customer audit outcomes with no critical findings.

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.

This is a hybrid position.