Manager, Regulatory Affairs

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

Salary Range : $99000- $125000/yr.

• 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 MTFs 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.

• Bachelors 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

At MTF Biologics we provide comprehensive benefits and resources to support our employees physical emotional and financial health.

• 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)

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