Regulatory Affairs Leader: FDA/ISO Compliance & Strategy

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

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.