Regulatory Affairs Specialist II – MedTech & Orthopaedics

6029-MEDICAL DEVICE BUSINESS SERVICES, INC. Legal Entity; Warsaw (VA); On-site; USD 76,000 - 122,000; Full time

Benefits offered by this job

Vacation hours

Paid holidays

Job summary

Johnson & Johnson is seeking a Regulatory Affairs Specialist II to execute regulatory activities for DePuy Synthes Joint Reconstruction and VELYS Digital Surgery products. You will prepare regulatory submissions, review changes for compliance, and collaborate with cross-functional teams to ensure timely approvals in multiple regions.

The role emphasizes regulatory judgment, quality systems knowledge, and strong communication skills to support marketed devices and new product development.

Qualifications

• BA/BS degree with minimum 2 years Regulatory Affairs experience in medical devices.
• Experience with US FDA Regulations and European Medical Device Regulations is required.
• Excellent written and oral communications skills.
• Familiarity with electronic submission preparation.

Responsibilities

• Prepare and/or assist in preparation of regulatory documentation for DePuy devices (IDE, 510(k), PMA, Technical File, Design Dossier).
• Assist in preparation of approval documents for rest of world registrations (EU CE marking).
• Review engineering changes for regulatory impact and document decisions.
• Provide regulatory guidance to project teams and review promotional materials for compliance.
• Maintain knowledge of applicable regulatory standards (FDA QSR, ISO 13485, MDR/MDD).
• Communicate business issues to management and ensure compliance with company policies.

Skills

Regulatory knowledge

Regulatory writing

Regulatory submission

Attention to detail

Education

BA/BS in relevant field

Job description

Johnson & Johnson is seeking a Regulatory Affairs Specialist II to execute regulatory activities for DePuy Synthes Joint Reconstruction and VELYS Digital Surgery products. You will prepare regulatory submissions, review changes for compliance, and collaborate with cross-functional teams to ensure timely approvals in multiple regions.

The role emphasizes regulatory judgment, quality systems knowledge, and strong communication skills to support marketed devices and new product development.