Global Regulatory Affairs Manager — Strategy & Compliance

MTF Biologics; Edison (NJ); On-site; USD 150,000 - 190,000; Full time

Job summary

MTF Biologics is seeking a Regulatory Affairs leader to oversee day-to-day operations, staff development, and strategic regulatory activities for U.S. and international markets.

You will manage submissions, inspections, audits, labeling, and design control support while ensuring ISO 9001/13485 alignment and continuous process improvements. Travel up to 20% to locations and suppliers will be required.

Qualifications

• Experience leading Regulatory Affairs teams
• Proven track record with FDA and international submissions
• Budget planning and expense control experience
• Strong knowledge of ISO 9001/13485 and regulatory standards
• Ability to coordinate regulatory strategies and inspections
• Excellent communication with senior management and regulators

Responsibilities

• Lead Regulatory Affairs staff and implement staffing plans
• Manage departmental budget and track budget vs. actual
• Oversee preparation and submission of U.S. and international filings
• Maintain licenses, accreditations, and certifications
• Develop regulatory strategies to support new products and tissues
• Serve as primary contact during inspections and audits
• Coordinate with VP and senior leadership on regulatory issues
• Engage with federal/state agencies and notified bodies on regulations

Skills

Regulatory leadership

Regulatory submissions

Budget management

FDA/Global regulatory

Audits & inspections

Quality system management

Staff coaching & development

Job description

MTF Biologics is seeking a Regulatory Affairs leader to oversee day-to-day operations, staff development, and strategic regulatory activities for U.S. and international markets.

You will manage submissions, inspections, audits, labeling, and design control support while ensuring ISO 9001/13485 alignment and continuous process improvements. Travel up to 20% to locations and suppliers will be required.