Regulatory Affairs Specialist II – MedTech Devices

Regulatory Jobs; Warsaw (IN); On-site; USD 76,000 - 122,000; Full time

Benefits offered by this job

Vacation time

Sick leave

Holiday pay

Parental Leave

Bereavement Leave

Employee benefits

Job summary

Johnson & Johnson is seeking a Regulatory Affairs Specialist II to support DePuy Synthes products in a multi-location environment, including Warsaw, IN and other U.S. sites.

The role requires preparing regulatory submissions (IDE, 510(k), PMA) and coordinating with agencies to maintain compliance for Orthopaedics and VELYS Digital Surgery lines. Strong writing, cross-functional collaboration, and attention to detail are essential.

Qualifications

• BA/BS degree with minimum 2 years Regulatory Affairs experience in medical devices.
• Experience with US FDA Regulations and European Medical Device Regulations.

Responsibilities

• Prepare and/or assist in preparation of regulatory documentation (IDE, 510(k), PMA, Technical File, Design Dossier).
• Assist with EU CE marking activities and other registrations as required.
• Review engineering changes for regulatory impact and submit documentation as needed.
• Determine regulatory impact of manufacturing changes and license status.
• Review labeling to ensure compliance with premarket clearances and approvals.
• Provide regulatory guidance to project teams and review promotional materials.

Skills

Analytical Reasoning

Regulatory Writing

Regulatory Strategy

Communication

Cross-functional Collaboration

Detail-Oriented

Regulatory Submissions

Project Management

Education

BA/BS degree in a related field

Job description

Johnson & Johnson is seeking a Regulatory Affairs Specialist II to support DePuy Synthes products in a multi-location environment, including Warsaw, IN and other U.S. sites.

The role requires preparing regulatory submissions (IDE, 510(k), PMA) and coordinating with agencies to maintain compliance for Orthopaedics and VELYS Digital Surgery lines. Strong writing, cross-functional collaboration, and attention to detail are essential.