Regulatory Affairs Specialist II - Orthopaedics Devices

Johnson & Johnson MedTech; West Chester (Chester County); Sur place; USD 76 000 - 122 000; Plein temps

Résumé du poste

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

The role requires knowledge of FDA MDR/MDR, EU CE marking, and ongoing regulatory guidance to project teams. A BS degree and 2+ years of experience are expected.

Qualifications

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

Responsabilités

• Prepare regulatory documentation for DePuy devices including IDE, 510(k), PMA, and Technical Documentation.
• Assist with EU CE marking activities and registrations.
• Review engineering changes for regulatory impact and decision documentation.
• Assess regulatory impact of manufacturing changes and license status.
• Review labeling and product support information for compliance with regulations.
• Provide regulatory guidance to project teams and review promotional materials.
• Maintain knowledge of FDA QSR, MDR, ISO 13485, and related standards.
• Communicate business issues to management and ensure health/safety compliance.

Connaissances

Regulatory affairs

Medical devices knowledge

Communication skills

Regulatory submissions

Formation

BA/BS degree

Outils

Electronic submissions

Description du poste

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

The role requires knowledge of FDA MDR/MDR, EU CE marking, and ongoing regulatory guidance to project teams. A BS degree and 2+ years of experience are expected.