Regulatory Affairs Manager

Responsibilities

• Lead, coach, and develop Regulatory Affairs staff
• Perform active management and observations of staff for compliance with regulations and process efficiencies
• Manage the budget for Regulatory Affairs department, including salaries, benefits, external vendors/consultants, supplies, services and internal expenses
• Formulate/submit budgets and manage to expense within budget requirements
• Track 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)
• Maintain all applicable licenses, accreditations (AATB), and ISO 9001 / 13485 certifications
• Develop regulatory strategies and pathways to support the regulatory designation of new products and tissues
• Communicate and coordinate with VP and MTF senior management and other department heads on regulatory issues and strategies
• Communicate with federal/state regulatory agencies, international government and notified bodies regarding applicable new or revised regulations and standards
• Assist on special projects and perform additional duties as assigned

Qualifications

• Bachelor’s degree in a relevant field (e.g., Biomedical Engineering, Regulatory Science, etc.)
• Minimum of 7 years of experience in Regulatory Affairs, including experience in leading and developing teams
• Experience with FDA, CE Marking, and other international regulatory processes
• Strong knowledge of regulatory guidelines and standards, including ISO 13485 and Good Manufacturing Practices (GMP)
• Excellent communication and interpersonal skills, with the ability to interact effectively with senior management and external stakeholders
• Ability to travel up to 20% of time to MTF locations and to suppliers as required