Manager, Regulatory Affairs

MTF Biologics•Edison, NJ

1d•$99,000 - $125,000•Onsite

About The Position

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.

Requirements

Bachelor's degree in a scientific or related field, or a combination of education and equivalent work experience
7+ Years of overall experience
5 Years of Managerial experience
5 Years or Human tissue or medical device manufacturing
Thorough understanding of FDA, QSR, cGMP, ISO regulations for medical devices, diagnostics or pharma
Must exhibit people management, effective communication skills
Attention to detail, critical thinking, problem-solving, and organizational skills
Prior experience handling FDA inspections for medical devices, diagnostics, biologics and/or pharma
Demonstrated success in obtaining US FDA regulatory clearance/approval for medical technologies
Ability to travel up to 20% of time to MTF locations and to suppliers as required

Responsibilities

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.