Regulatory Affairs Specialist II - Orthopedics MedTech

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

Job summary

Johnson & Johnson’s Orthopaedics Regulatory Affairs team seeks a Regulatory Affairs Specialist II to support marketed devices and new development. You will collaborate with cross‑functional partners to plan and execute regulatory submissions, ensuring compliance with FDA, EU MDR, and ISO 13485 standards.

Based in U.S. locations including Boston, MA, you will review changes, support labeling, and guide regulatory strategy for DePuy Synthes products and Velys Digital Surgery platforms.

Qualifications

• BA/BS degree with minimum 2 years Regulatory Affairs experience in medical devices.
• Experience with US FDA Regulations and European Medical Device Regulations (and previous Medical Device Directives) required.
• Excellent written and oral communications skills.
• Ability to handle multiple tasks and be detail oriented.
• Knowledge of medical devices, with preference for orthopaedics, capital equipment, robotics, and software.
• Familiarity with electronic submission preparation.

Responsibilities

• Prepare and/or assist in preparation of regulatory documentation for DePuy devices, including IDE, 510(k), PMA, Technical File, Design Dossier, and Technical Documentation for submission to regional Health authorities.
• Assist in the preparation of approval documents to support rest of world registrations, such as EU CE marking activities.
• Review engineering changes to currently marketed products and prepare internal regulatory assessments for documenting decisions to submit or not to submit in accordance with relevant regulations.
• Determine regulatory impact of manufacturing and/or changes on products, prepare and submit applications, and assess the impact on regulatory licenses.
• Review product labeling and product support information for currently marketed products to ensure alignment with premarket clearances and approvals.
• Provide regulatory guidance and support to project teams including design control changes and review of promotional materials.
• Maintain current knowledge to ensure compliance with FDA QSR, European MDR/MDD, ISO 13485, and related standards.
• Communicate business issues or opportunities to management; follow company HSE guidelines.
• Ensure personnel and resources comply with all applicable regulations and policies.

Skills

Regulatory Affairs

Medical devices knowledge

Regulatory submissions

Communication skills

Attention to detail

Education

Bachelor's degree

Tools

Electronic submission tools

Job description

Johnson & Johnson’s Orthopaedics Regulatory Affairs team seeks a Regulatory Affairs Specialist II to support marketed devices and new development. You will collaborate with cross‑functional partners to plan and execute regulatory submissions, ensuring compliance with FDA, EU MDR, and ISO 13485 standards.

Based in U.S. locations including Boston, MA, you will review changes, support labeling, and guide regulatory strategy for DePuy Synthes products and Velys Digital Surgery platforms.