Principal Specialist, Regulatory Affairs (Medical Devices)

Location: Round Lake, Illinois, United States. Applicants must be authorized to work for any employer in the U.S.; visa sponsorship is not available.

Salary: $104,000–$143,000 annually, plus potential discretionary bonuses.

Company

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

What you will do

• Manage regulatory approvals, registrations, change assessments, and lifecycle compliance for medical device products.
• Develop regulatory strategies and submission plans for product changes, process changes, and new market introductions.
• Prepare U.S. regulatory filings, including 510(k) submissions, pre-submissions, and responses to FDA requests.
• Maintain EU MDR technical documentation and evaluate regulatory requirements across international markets.
• Support interactions with Notified Bodies and regulatory authorities.
• Partner with Regulatory Affairs, R&D, Quality, Marketing, Operations, and international regulatory teams.

Requirements

• Bachelor’s degree in a scientific or engineering discipline.
• At least 5 years of regulatory experience in the medical device industry.
• Experience with FDA change assessment guidance and EU MDR technical documentation.
• Successful preparation and submission of 510(k) filings.
• Ability to interpret scientific and technical information, document regulatory decisions, and defend submission strategies.
• Strong communication, presentation, negotiation, risk assessment, project management, and cross-functional influence skills.

Nice to have

• Experience with electromechanical medical devices.
• Familiarity with global registrations beyond the U.S. and EU.

Culture & Benefits

• Collaborative, matrixed, multinational, and multicultural working environment.
• Medical and dental coverage starting on day one for eligible employees.
• 401(k) retirement plan with employee contributions and company matching, plus an Employee Stock Purchase Plan.
• Paid holidays, 20–35 days of paid time off based on length of service, family and medical leave, and paid parental leave.
• Flexible Spending Accounts, educational assistance, disability insurance, commuting benefits, childcare benefits, and employee assistance programs.