Regulatory Affairs Manager

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

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.