Regulatory Affairs Specialist II – MedTech Devices

Johnson & Johnson Innovative Medicine; Florida; On-site; USD 76,000 - 122,000; Full time

Job summary

Johnson & Johnson Innovative Medicine in the United States is seeking a Regulatory Affairs Specialist II to execute regulatory activities supporting marketed devices and new product development in the DePuy Synthes Joint Reconstruction and VELYS Digital Surgery line. You will collaborate cross-functionally to drive regulatory submissions and ensure compliance.

This role requires a BA/BS with 2+ years in regulatory affairs for medical devices, plus knowledge of FDA and European MDR/IVD

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

Responsibilities

• Prepare regulatory documentation for DePuy devices (IDE, 510(k), PMA, Technical File, Design Dossier).
• Assist with EU CE marking and rest-of-world registrations.
• Review engineering changes for regulatory impact and document decisions.
• Determine regulatory impact of manufacturing changes and submit applications as needed.
• Review labeling and promotional materials for compliance with regulations.
• Provide regulatory guidance to project teams and support design control changes.

Skills

Regulatory Affairs

FDA Regulations

Medical Devices

Education

BA/BS degree

Job description

Johnson & Johnson Innovative Medicine in the United States is seeking a Regulatory Affairs Specialist II to execute regulatory activities supporting marketed devices and new product development in the DePuy Synthes Joint Reconstruction and VELYS Digital Surgery line. You will collaborate cross-functionally to drive regulatory submissions and ensure compliance.

This role requires a BA/BS with 2+ years in regulatory affairs for medical devices, plus knowledge of FDA and European MDR/IVD