Senior Regulatory Affairs Specialist - MedTech Ortho

Brighter Signals; Warsaw (IN); On-site; USD 79,000 - 128,000; Full time

Job summary

Johnson & Johnson seeks a Senior Regulatory Affairs Specialist to support regulatory submissions for DePuy Joint Reconstruction devices. The role involves preparing IDE, 510(k), PMA, and Technical Documentation, ensuring compliance with FDA, EU MDR, and other global regulations.

The position requires a BA/BS and 2+ years in regulatory affairs, with favorable knowledge of orthopedic implants and electronic submissions. Offices across the U.S. support a dynamic medical devices portfolio.

Qualifications

• Minimum 2 years of regulatory affairs experience in medical devices.
• Familiarity with U.S. FDA and EU MDR regulations is a plus.
• Experience with orthopedic implants is a plus.
• Excellent written and verbal communication skills.

Responsibilities

• Prepare regulatory documentation for DePuy devices (IDE, 510(k), PMA, Technical Files) for regulatory submission.
• Support global registration activities (Japan, China, Australia, NZ).
• Ensure compliance with Health Authority requirements and company policies.

Skills

Regulatory affairs

Regulatory submissions

FDA regulations

EU MDR

Education

BA/BS degree

Tools

Electronic submissions

Job description

Johnson & Johnson seeks a Senior Regulatory Affairs Specialist to support regulatory submissions for DePuy Joint Reconstruction devices. The role involves preparing IDE, 510(k), PMA, and Technical Documentation, ensuring compliance with FDA, EU MDR, and other global regulations.

The position requires a BA/BS and 2+ years in regulatory affairs, with favorable knowledge of orthopedic implants and electronic submissions. Offices across the U.S. support a dynamic medical devices portfolio.