Sr Mgr, Regulatory Affairs

Location: Deerfield, Illinois, United States

Salary: $152,000–$209,000 annually, with potential discretionary bonuses

Company

hirify.global develops healthcare products and solutions focused on its mission to save and sustain lives.

What you will do

• Lead global regulatory affairs for hemostat and sealant products registered as biologic or combination products.
• Develop and execute regulatory strategies supporting product approvals, lifecycle management, marketing authorizations, and ongoing compliance.
• Evaluate regulatory requirements, new regulations, technical and scientific information, deficiencies, and compliance risks.
• Develop and implement risk mitigation and remediation strategies aligned with business objectives.
• Plan and lead meetings with regulatory authorities and manage complex cross-functional projects.
• Coordinate communication with Regulatory Affairs, Global Marketing, and project teams while mentoring junior colleagues on US regulatory requirements and submission strategies.

Requirements

• Bachelor’s degree or country equivalent in a scientific discipline.
• Minimum 7 years of regulatory affairs experience and expert regulatory knowledge.
• Scientific training or communications knowledge, management skills, and experience overseeing multiple projects in a matrix environment.
• Excellent oral, written, presentation, interpersonal, collaboration, negotiation, and diplomacy skills.
• Ability to lead, coach, motivate, and achieve results through others in a multinational and multicultural environment.
• Applicants must be authorized to work for any employer in the United States; employment visa sponsorship or transfer is not available.

Nice to have

• Master’s degree and/or PhD.

Culture & Benefits

• Culture centered on courage, trust, collaboration, ownership, and accountability.
• Medical and dental coverage starting on day one, plus life, accident, disability, and business travel insurance.
• 401(k) retirement savings plan with employee contributions and company matching, ESPP, and flexible spending accounts.
• Educational assistance, paid holidays, 20–35 days of paid time off based on length of service, family and medical leave, and paid parental leave.
• Additional commuting, childcare, employee discount, and employee assistance benefits.