Senior Regulatory Affairs Specialist (Medtech)

TL;DR

Senior Regulatory Affairs Specialist (Medtech): Developing and implementing regional regulatory strategies for resuscitation products with an accent on device approval and compliance. Focus on authoring technical submittals, managing risk assessments, and providing strategic guidance to cross-functional project teams.

Location: Must be based in the US (Hybrid/Remote)

Salary: $101,600–$152,400

Company

A global medical device company dedicated to improving patient outcomes through innovative resuscitation and critical care technologies.

What you will do

• Develop and implement regional regulatory strategies for new and sustaining products.
• Author and prepare submittals for IDEs, 510(k), PMAs, and Technical Files.
• Provide strategic regulatory perspective during product development and commercialization.
• Collaborate with cross-functional teams to ensure regulatory requirements are met.
• Lead and coordinate internal and external resources for audit and compliance activities.
• Monitor and report on key performance indicators to support continuous improvement.

Requirements

• Bachelor's degree required (Advanced degree preferred).
• 5+ years of regulatory affairs experience, preferably in the medical device industry.
• Proven experience with electro-mechanical products.
• Strong written and verbal communication skills for stakeholder management.
• Ability to create action plans and manage project deliverables.
• Must be authorized to work in the US.

Nice to have

• Regulatory Affairs Certification (RAC).
• Experience in electro-cardiology, defibrillation, or respiratory medical spaces.

Culture & Benefits

• Comprehensive benefits package including health, dental, and vision plans.
• Annual bonus eligibility based on company performance.
• Commitment to a culture of innovation and continuous improvement.
• Opportunities for career growth within a global, fast-growing organization.
• Supportive environment focused on saving lives and improving patient outcomes.