Manager, Regulatory Affairs (Medtech)

Location: Deerfield, Illinois, United States; hybrid workplace with a required minimum number of onsite days.

Salary: $120,000–$165,000 annually.

Company

hirify.global develops healthcare products and solutions focused on improving healthcare delivery and sustaining lives.

What you will do

• Develop and execute regulatory strategies for new product development and product lifecycle management.
• Lead regulatory activities for assigned product portfolios, including submissions, approvals, and compliance commitments.
• Assess regulatory risks, perform gap assessments, and implement mitigation and process improvements.
• Monitor global regulatory requirements and develop, document, and defend regulatory positions.
• Act as the primary contact for health authorities and regulatory agencies.
• Partner with cross-functional teams and lead, coach, and develop regulatory team members.

Requirements

• Bachelor's degree in a scientific discipline or equivalent.
• 5+ years of Regulatory Affairs or related experience in a regulated industry.
• Experience leading projects, cross-functional initiatives, and people management responsibilities.
• Knowledge of global regulatory requirements, guidance documents, compliance expectations, and submission processes.
• Experience with complex product development programs, marketed product portfolios, global submissions, and health-authority interactions.
• Must be authorized to work for any employer in the United States.

Nice to have

• Experience representing Regulatory Affairs in industry organizations, trade associations, or external working groups.
• Experience in multinational and multicultural business environments.

Culture & Benefits

• Collaborative environment centered on courage, trust, ownership, and accountability.
• Flexible workplace policy with required onsite attendance.
• Medical, dental, life, disability, and business travel accident insurance.
• 401(k) retirement plan, employee stock purchase plan, flexible spending accounts, and educational assistance.
• Paid time off, holidays, family and medical leave, and paid parental leave.

Hiring process

• External applicants receiving an offer are eligible for a $5,000 sign-on bonus after completing the first 30 days.
• Visa sponsorship is not available.