Senior Regulatory Affairs Program Specialist

For our client, we are seeking a Senior Regulatory Affairs Program Specialist to join the team of a leader in the Healthcare space. 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. The position offers the opportunity to bring clarity to complex work and deliver outcomes that matter across the organization within a healthcare environment.

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

Compensation: $105,000 – $125,000 annually

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

Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.