Senior Regulatory Affairs Program Specialist

This role will drive complex programs from planning through execution with a focus on structure, accountability, and measurable delivery. You will work across business leaders, delivery teams, and strategic partners to align priorities, manage dependencies, and keep initiatives on track in a healthcare environment.

Responsibilities

• Evaluate and resolve regulatory and technical issues
• Lead compliance initiatives for technical medical devices
• Drive education on regulatory compliance for stakeholders
• Serve as a subject matter expert for regulatory teams
• Review global regulatory submissions for accuracy
• Support technical inquiries for global market entry
• Collaborate to enhance design documentation efficiencies

Qualifications

• Bachelor's Degree required
• 5+ years of regulatory experience in the Medical Device Industry
• Experience working with Regulatory Authorities on premarket and compliance activities
• Strong understanding of regulatory trends in medical device manufacturing
• Proven analytical abilities and problem-solving skills

Benefits

• Comprehensive benefits package
• Eligible for an annual bonus
• Supportive team environment and opportunities for professional growth
• Continuous training of key personnel on regulatory updates
• Participation in regulatory audits and compliance initiatives

Pay

$105,000 – $125,000 annually

Location: Remote - US based candidates only, no visa sponsorship available