Regulatory Affairs Manager

MTF Biologics; Edison (NJ); On-site; USD 140,000 - 190,000; Full time

Job summary

MTF Biologics in Edison, NJ seeks a Regulatory Affairs leader to oversee day-to-day operations and ensure effective execution of U.S. and international regulatory activities.

You will manage staff, budgets, and regulatory submissions, including inspections and audits, while maintaining licenses and quality systems certifications such as ISO 9001/13485.

Qualifications

• Leads Regulatory Affairs staff and coordinates staffing plans and performance management.
• Oversees regulatory submissions, inspections, audits, recalls and labeling activities.
• Maintains licenses and certifications (AATB, ISO 9001/13485).
• Participates in regulatory strategy development and pathways for new tissues/products.

Responsibilities

• Lead, coach, and develop Regulatory Affairs staff with performance management and training.
• Assist in managing department budget, including tracking budget-to-actual performance.
• Oversee preparation, submission, and maintenance of US and international regulatory filings (FDA, CE, Canada, Australia).
• Ensure licenses and accreditations are maintained.
• Serve as primary regulatory contact during inspections, audits, and regulatory intelligence.

Skills

Regulatory leadership

FDA submissions

Quality systems

Budget management

Staff coaching

Job description

Responsible for the day-to-day leadership and operational management of the Regulatory Affairs function. This role oversees Regulatory Affairs personnel and ensures effective execution of U.S. and international regulatory activities, including regulatory submissions, inspections and audits, recalls, licensing, labeling and promotional review, quality system documentation, risk management, and design control support. Ability to travel up to 20% of time to MTF locations and to suppliers as required

Monday through Friday 8:15am to 4:30pm

• Lead, coach, and develop Regulatory Affairs staff, including staffing plans, performance management, training, and competency maintenance. Also performs active management and observations of staff for compliance with regulations and process efficiencies.
• Assist in managing the budget for Regulatory Affairs department, including salaries, benefits, external vendors/consultants, supplies, services and internal expenses. Responsible for formulating/submitting budgets and managing to expense within budget requirements. Tracks monthly "budget to actual" performance.
• Oversee and assist in the preparation, submission, and maintenance of U.S. and international regulatory filings (FDA, CE Marking, Canada, Australia, and other global markets).
• Ensure maintenance of all applicable licenses, accreditations (AATB), and ISO 9001 / 13485 certifications.
• Participates in the development of regulatory strategies and pathway to support the regulatory designation of new products and tissues.
• Serve as a primary regulatory contact during inspections and audits and lead regulatory intelligence activities.
• Communicates and coordinates with VP and MTF senior management and other department heads on regulatory issues and regulatory strategies which may impact MTF's ability to fulfill its mission.
• Communicates with federal/state regulatory agencies, international government and notified bodies, and AATB related to applicable new or revised regulations and standards
• Assist on special projects and performs additional duties as assigned.