Manager, Regulatory Affairs

Jobtailor; Edison (NJ); On-site; USD 150,000 - 230,000; Full time

Job summary

Jobtailor in Edison, NJ seeks a senior Regulatory Affairs leader to coach and grow a team, manage regulatory filings, and ensure compliance across US and international programs.

Ideal candidates have extensive FDA/QSR/cGMP knowledge, strong budgeting skills, and a proven track record in medical devices or tissue-related sectors. Occasional travel to MTF sites and suppliers is required.

Qualifications

• Bachelor's degree in a scientific or related field or equivalent experience.
• 7+ years of overall experience with 5+ years in management.
• 5+ years in human tissue or medical device manufacturing.
• Thorough understanding of FDA, QSR, cGMP, ISO regulations for medical devices, diagnostics or pharma.
• People management and effective communication skills.
• Travel up to 20% to MTF locations and suppliers.

Responsibilities

• Lead, coach, and develop Regulatory Affairs staff including staffing plans and performance management.
• Manage staff compliance with regulations and process efficiencies.
• Assist in managing the department budget and track monthly performance.
• Oversee regulatory filings for US and international markets.
• Maintain licenses, AATB accreditations, and ISO 9001/13485 certifications.
• Participate in regulatory strategies and pathways for new products.
• Serve as primary regulatory contact during inspections and audits.
• Lead regulatory intelligence activities.
• Coordinate with senior management on regulatory issues and strategies.
• Communicate with federal/state agencies and international bodies on regulations.

Skills

Regulatory leadership

Budget management

People management

Regulatory intelligence

FDA inspections

QSR knowledge

cGMP compliance

Attention to detail

Communication

Training development

Education

Bachelor's degree in a scientific or related field

Tools

AATB Accreditation

ISO 9001 Certification

ISO 13485 Certification

Job description

• Lead, coach, and develop Regulatory Affairs staff, including staffing plans, performance management, training, and competency maintenance
• Manage staff compliance with regulations and process efficiencies
• Assist in managing the Regulatory Affairs department budget, including salaries, benefits, vendors/consultants, supplies, services, and internal expenses
• Formulate and submit budgets and track monthly budget-to-actual performance
• Oversee and assist with preparation, submission, and maintenance of U.S. and international regulatory filings
• Ensure maintenance of applicable licenses, AATB accreditations, and ISO 9001/13485 certifications
• Participate in regulatory strategies and pathways for new products and tissues
• Serve as primary regulatory contact during inspections and audits
• Lead regulatory intelligence activities
• Coordinate with VP, senior management, and department heads on regulatory issues and strategies
• Communicate with federal/state agencies, international governments, notified bodies, and AATB regarding regulations and standards
• Assist with special projects and additional assigned duties

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
• People management and 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
• Standard business hours Monday through Friday, 8:15am–4:30pm EST

Core Competencies

Demonstrates expertise in Regulatory Affairs with a strong focus on FDA, QSR, cGMP, and ISO regulations for medical devices and diagnostics. Proven ability to lead teams, manage budgets, and ensure compliance while effectively communicating with regulatory bodies.

Highest-signal resume keywords

• Regulatory Affairs Leadership
• FDA Regulatory Clearance
• Budget Management
• ISO 9001/13485 Certification
• People Management

ATS Optimization Keywords

Hard Skills

• Regulatory Filings
• Budget Formulation
• FDA Inspections
• CGMP Compliance
• QSR Knowledge
• Critical Thinking
• Problem-Solving
• Attention to Detail
• Performance Management
• Training Development

Soft Skills

• Effective Communication
• Organizational Skills

Certifications & Qualifications

• AATB Accreditation
• ISO 9001 Certification
• ISO 13485 Certification

Industry Keywords

• Medical Device Manufacturing
• Human Tissue
• Diagnostics
• Pharmaceuticals
• Regulatory Strategies