Senior Manager, Regulatory Affairs (MedTech)

Location: Lake Zurich, Illinois, United States; onsite three days per week with remaining days available remotely

Salary: $160,000–$170,000 annually, plus eligibility for an annual bonus with a 14% target

Company

hirify.global is a healthcare company operating in medical technology and regulated pharmaceutical products.

What you will do

• Own regulatory decision-making and strategy for complex or high-risk products, projects, regions, and regulatory initiatives.
• Prepare, coordinate, and provide senior technical oversight for US and international submissions, including 510(k) and NDA supplements where applicable.
• Serve as the senior Regulatory Affairs lead on cross-functional product and project teams, aligning regulatory strategies with business objectives.
• Monitor evolving regulatory and import/export requirements and ensure applicable product compliance.
• Review and approve product labeling and advertising or promotional materials for regulatory compliance.
• Lead Health Authority interactions and maintain post-market obligations, including annual reports, PADERs, PSURs, and PMS/PMCF reports where applicable.

Requirements

• Bachelor’s degree and 8 or more years of experience in a regulatory function.
• Strong technical, regulatory, and problem-solving skills with an understanding of device and/or drug requirements and submission processes.
• Experience developing and executing complex regulatory strategies or managing novel regulatory challenges.
• Advanced interpersonal skills, including conflict management and stakeholder influence.
• Demonstrated ability to collaborate effectively with regulatory agencies.
• Effective spoken and written English is required for all essential functions.

Nice to have

• Experience with infusion systems, transfusion technologies, cellular therapies, or drugs.

Culture & Benefits

• Hybrid work arrangement with three required onsite days per week.
• Medical, prescription drug, dental, and vision coverage.
• 401(k) plan with company contributions.
• Paid vacation, holidays, and personal days.
• Employee assistance, life insurance, disability coverage, and wellness programs.
• Visa sponsorship is not available now or in the future.