Senior Manager Regulatory Compliance (Pharmaceuticals and Medical Devices)

Location: Hybrid in Northfield, Illinois, United States; travel up to 35% within the state, out of state, and internationally

Salary: $154,000–$231,000 annual, plus bonus and/or incentive eligibility

Company

hirify.global is a growing worldwide organization producing and supporting regulated medical device, pharmaceutical, cosmetic, and OTC drug products.

What you will do

• Lead pharmaceutical validation engineering for compounding, filling, cleaning, facilities, utilities, equipment, and processes.
• Manage laboratory Quality Assurance programs, laboratory quality systems, and GLP compliance.
• Develop and improve global risk management programs, controls, strategies, and processes for regulated products and systems.
• Manage supplier validation plans, audit suppliers, and review and approve validation protocols and reports.
• Support FDA and ISO inspections, corrective action reviews, OOS investigations, root-cause analysis, and remediation opportunities.
• Lead personnel, budgets, policies, major programs, hiring, performance management, training, and global compliance training.

Requirements

• Bachelor’s degree with a scientific or engineering background.
• At least 5 years of multidisciplinary experience in medical device and pharmaceutical Quality Management Systems, including validations, risk management, and laboratory systems.
• At least 2 years of experience managing, hiring, developing, motivating, and directing people.
• Experience with FDA regulations, including 21 CFR 820 and 21 CFR 210/211.
• Experience with ISO 13485 and ISO 17025, MDSAP, and MDD/MDR regulations.
• Experience applying process validation, method validation, and GLP requirements.
• Experience with FDA inspections and FDA 483 response writing, as well as global risk management expectations.
• Willingness to work safely where hazardous chemicals may be encountered.
• Willingness to travel up to 35% for business purposes.

Nice to have

• Bachelor’s degree in engineering, chemistry, or biological sciences.
• Experience auditing FDA-regulated medical device or pharmaceutical compliance.
• Experience with regulated medical device or pharmaceutical risk management practices.
• Advanced Microsoft Word and Excel experience.

Culture & Benefits

• Full-time employment with health insurance, life and disability coverage, 401(k) contributions, and paid time off for eligible employees.
• Continuing education and training opportunities.
• Bonus and/or incentive eligibility.
• Inclusive workplace focused on belonging, diversity, and career growth.