Regulatory Affairs Specialist II — Orthopaedics MedTech

Brighter Signals; Raynham (MA); On-site; USD 76,000 - 122,000; Full time

Job summary

Johnson & Johnson is seeking a Regulatory Affairs Specialist II to execute regulatory activities for current and new orthopedic devices and digital surgery products. You will prepare submissions, support global registrations, and ensure compliance with FDA and European regulations.

The role requires a BA/BS with 2+ years of medical device regulatory experience, strong communication, and cross-functional collaboration in a fast-paced environment.

Qualifications

• BA/BS degree and minimum 2 years regulatory affairs experience for medical devices.
• Experience with US FDA Regulations and European Medical Device Regulations is required.
• Strong written and oral communication skills; detail-oriented with risk assessment abilities.

Responsibilities

• Prepare regulatory documentation for DePuy devices (IDE, 510(k), PMA, etc.).
• Assist with EU CE marking activities and other global registrations.
• Review engineering changes and assess regulatory impact on licenses.
• Support labeling, product documentation, and promotional material review.
• Provide regulatory guidance to project teams and maintain compliance with standards.

Skills

Regulatory knowledge

FDA Regulations

Regulatory docs

Communication skills

Education

BA/BS in related field

Tools

Electronic submissions

Job description

Johnson & Johnson is seeking a Regulatory Affairs Specialist II to execute regulatory activities for current and new orthopedic devices and digital surgery products. You will prepare submissions, support global registrations, and ensure compliance with FDA and European regulations.

The role requires a BA/BS with 2+ years of medical device regulatory experience, strong communication, and cross-functional collaboration in a fast-paced environment.