Manager, Regulatory Affairs

Responsibilities

• Lead, coach, and develop Regulatory Affairs staff, including staffing plans, performance management, training, and competency maintenance.
• 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).
• Ensure maintenance of 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.
• Participate in regulatory inspections and audits, leading regulatory intelligence activities.
• 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.
• Affiliate with special projects and perform additional duties as assigned.

Qualifications

• 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 of human tissue or medical device manufacturing experience.
• Thorough understanding of FDA, QSR, cGMP, ISO regulations for medical devices, diagnostics, or pharma.
• People management, effective communication, 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.

Benefits

Information at MTF Biologics provides comprehensive benefits and resources to support employees' physical, emotional, and financial health. These include:

• 4 weeks Paid Time Off (PTO)
• Paid Holidays
• Medical, Dental, Vision Insurance and Prescription Drug Insurance
• 401K plan with company match
• Short & Long Term Disability
• Life & Accidental Death Insurance
• Tuition Reimbursement
• Health Care/Dependent Care Flexible Spending Accounts
• Adoption Assistance
• Voluntary Benefits (e.g., Pet Insurance, Legal, home and auto insurance)
• Sword Health (at-home Physical Therapy)

Pay

$99,000 - $125,000/yr.

Schedule

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