Senior Regulatory Affairs Lead — Medical Devices

Regulatory Jobs; Chester (Delaware County); On-site; USD 92,000 - 148,000; Full time

Job summary

Johnson & Johnson - DePuy Synthes is seeking a Senior Regulatory Affairs Specialist for multiple locations, including West Chester, PA and Raynham, MA. You will coordinate submissions for medical devices, support lifecycle management, and ensure regulatory compliance across product lines.

The role requires 4–6 years in regulatory affairs, strong communication and organizational skills, and RAC certification is a plus.

Qualifications

• Excellent written and oral communication skills.
• Excellent organizational skills preferred.
• Ability to handle multiple tasks and be detail oriented.
• Ability to apply risk-benefit analysis techniques.
• RAC certification for Medical Devices preferred.

Responsibilities

• Provide regulatory input to product lifecycle management.
• Submit regulatory submissions to authorities.
• Monitor and respond to regulatory reports for orthopedic devices.
• Collaborate with Product Development for submissions.
• Review change requests and labeling requirements.
• Prepare registrations and medical device listings.
• Maintain regulatory database and SOPs.
• Develop regulatory strategies and update plans.

Skills

Communication skills

Organizational skills

Multitasking

Risk analysis

RAC certification

Education

University / bachelor’s degree or equivalent

Job description

Johnson & Johnson - DePuy Synthes is seeking a Senior Regulatory Affairs Specialist for multiple locations, including West Chester, PA and Raynham, MA. You will coordinate submissions for medical devices, support lifecycle management, and ensure regulatory compliance across product lines.

The role requires 4–6 years in regulatory affairs, strong communication and organizational skills, and RAC certification is a plus.