Regulatory Affairs Specialist II – Medical Devices

Biopharma Careers; Warsaw (IN); On-site; USD 76,000 - 122,000; Full time

Job summary

Johnson & Johnson in Warsaw, IN; multiple U.S. locations including Indiana, MA, FL, and PA, seeks a Regulatory Affairs Specialist II to execute regulatory activities for DePuy Synthes devices and VELYS Digital Surgery.

You will prepare regulatory submissions, review changes, and collaborate cross-functionally to ensure compliance with FDA, EU MDR, and ISO standards. The role requires 2+ years in medical device regulatory affairs, strong communication, and ability to manage multiple tasks in a

Qualifications

• BA/BS in regulatory affairs or related field.
• 2+ years regulatory affairs in medical devices.
• Experience with FDA and EU MDR.
• Strong written and oral communication.

Responsibilities

• Prepare regulatory documentation for devices (IDE, 510(k), PMA).
• Assist EU CE marking and registrations as required.
• Review changes and assess regulatory impact.
• Provide guidance to project teams on regulatory pathways.
• Maintain knowledge of standards (FDA QSR, ISO 13485, MDR).

Skills

Regulatory Affairs

FDA Regulations

EU MDR

Communication

Education

BA/BS degree

Tools

eCTD

Job description

Johnson & Johnson in Warsaw, IN; multiple U.S. locations including Indiana, MA, FL, and PA, seeks a Regulatory Affairs Specialist II to execute regulatory activities for DePuy Synthes devices and VELYS Digital Surgery.

You will prepare regulatory submissions, review changes, and collaborate cross-functionally to ensure compliance with FDA, EU MDR, and ISO standards. The role requires 2+ years in medical device regulatory affairs, strong communication, and ability to manage multiple tasks in a