Principal Specialist, Regulatory Affairs (Medical Devices)

Location: Round Lake, Illinois, United States; hybrid workplace with a required minimum number of onsite days per week. Applicants must be authorized to work for any employer in the U.S.

Base salary: $104,000–$143,000 annually. A $5,000 sign-on bonus is offered to eligible external applicants after the first 30 days.

Company

Global healthcare company focused on medical products and solutions that help save and sustain 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 support interactions with Notified Bodies and regulatory authorities.
• Review technical, scientific, and quality information to assess regulatory impact and support product changes.
• Coordinate global submission planning and compliance activities with Regulatory Affairs, R&D, Quality, Marketing, Operations, and international regulatory colleagues.

Requirements

• Bachelor’s degree in a scientific or engineering subject area.
• At least 5 years of regulatory experience in the medical device industry.
• Experience with FDA change assessment guidance, EU MDR technical documentation, and successful preparation and submission of 510(k)s.
• Knowledge of global registrations beyond the U.S. and EU, scientific information interpretation, and regulatory risk assessment.
• Ability to document and defend regulatory decisions, influence cross-functional partners, manage multiple timelines, and communicate effectively.
• U.S. work authorization is required; visa sponsorship or transfer of employment visa sponsorship is not available.

Nice to have

• Experience with electromechanical medical devices.
• Experience working in a multinational and multicultural team environment.

Culture & Benefits

• Flexible workplace policy combining onsite collaboration with workplace flexibility.
• Medical and dental coverage starting on day one for eligible roles.
• 401(k) retirement plan with company matching, employee stock purchase plan, and flexible spending accounts.
• Paid holidays, paid time off, family and medical leave, and paid parental leave.
• Educational assistance, commuting benefits, childcare benefits, employee assistance, and employee discount programs.