Regulatory Affairs Specialist II – MedTech Orthopedics

Johnson & Johnson MedTech; Raynham (MA); Presencial; USD 76 000 - 122 000; Tempo integral

Resumo da oferta

Johnson & Johnson MedTech seeks a Regulatory Affairs Specialist II to execute regulatory activities for DePuy Synthes Joint Reconstruction and VELYS Digital Surgery products. The role combines regulatory judgment with cross-functional teamwork to drive product approvals and market access.

You will prepare regulatory submissions (IDE, 510(k), PMA, CE marking), review changes for regulatory impact, and guide teams on labeling and compliance with FDA, EU MDR, and ISO 13485.

Qualificações

• 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

Responsabilidades

• Prepare 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 EU CE marking activities and rest of world registrations as required.
• Review engineering changes and prepare internal regulatory assessments for submissions.
• Determine regulatory impact of manufacturing changes and submissions for products and licenses.
• Review product labeling and support information for compliance with premarket clearances and approvals.
• Provide regulatory guidance to project teams and review promotional materials for regulatory pathways.
• Maintain current knowledge to ensure compliance with FDA QSR, EU MDR/IVD, ISO 13485, and related standards.
• Communicate business issues or opportunities to management.
• Ensure adherence to Health, Safety and Environmental guidelines.
• If supervising, ensure subordinates follow guidelines and resources are available.
• Perform other duties as needed.

Conhecimentos

Regulatory Affairs

Medical devices

FDA Regulations

Formação académica

BA/BS degree

Descrição da oferta de emprego

Johnson & Johnson MedTech seeks a Regulatory Affairs Specialist II to execute regulatory activities for DePuy Synthes Joint Reconstruction and VELYS Digital Surgery products. The role combines regulatory judgment with cross-functional teamwork to drive product approvals and market access.

You will prepare regulatory submissions (IDE, 510(k), PMA, CE marking), review changes for regulatory impact, and guide teams on labeling and compliance with FDA, EU MDR, and ISO 13485.