Regulatory Affairs Manager - Global Submissions

Musculoskeletal Transplant Foundation; Edison (NJ); On-site; USD 99,000 - 125,000; Full time

Benefits offered by this job

4 weeks Paid Time Off (PTO)

401K plan with company match

Medical, Dental, Vision Insurance

Job summary

The Musculoskeletal Transplant Foundation in Edison, NJ, is seeking a Regulatory Affairs Manager to oversee regulatory submissions, inspections, and audits. This role includes managing the Regulatory Affairs team, budget, and compliance with U.S. and international regulations.

The ideal candidate has over 7 years of experience in regulatory affairs, with 5 years in a managerial capacity. Great benefits including paid time off, healthcare, and 401K plan are offered.

Qualifications

• 7+ years of overall experience in regulatory affairs.
• 5 years of managerial experience in a related field.
• Thorough understanding of FDA, QSR, cGMP regulations.

Responsibilities

• Lead and develop Regulatory Affairs staff.
• Manage budget for Regulatory Affairs department.
• Oversee preparation and submission of regulatory filings.
• Serve as primary regulatory contact during inspections.

Skills

Regulatory compliance

People management

Critical thinking

Problem-solving

Communication skills

Education

Bachelor's degree in a scientific or related field

Job description

The Musculoskeletal Transplant Foundation in Edison, NJ, is seeking a Regulatory Affairs Manager to oversee regulatory submissions, inspections, and audits. This role includes managing the Regulatory Affairs team, budget, and compliance with U.S. and international regulations.

The ideal candidate has over 7 years of experience in regulatory affairs, with 5 years in a managerial capacity. Great benefits including paid time off, healthcare, and 401K plan are offered.