Senior Regulatory Affairs Specialist

Johnson Johnson; Warsaw (IN); On-site; USD 120,000 - 180,000; Full time

Job summary

Johnson & Johnson seeks a Senior Regulatory Affairs Specialist to support regulatory activities for DePuy Joint Reconstruction devices. The role focuses on preparing regulatory documentation for submissions (IDE, 510(k), PMA) and ensuring labeling and claims align with global requirements.

You will drive global registration activities and ensure compliance with the Health Care Compliance Program and relevant regulations, across multiple sites in the US.

Qualifications

• Regulatory activities for medical devices in DePuy Joint Reconstruction.
• Preparation of regulatory submissions including IDE, 510(k) and PMA.
• Ensure labeling and promotional materials comply with global regulations.

Responsibilities

• Prepares regulatory documentation for DePuy devices for IDE, 510(k), PMA, and Design Dossiers.
• Supports global registration activities (Japan, China, Australia, NZ).
• Ensures compliance with Health Care Compliance Program and Code of Conduct.
• Guides conformance with regulations in product development and labeling.
• Reviews changes with Product Lifecycle Management for Notified Body, FDA, and Global impact.
• Reviews labeling and support information for marketed products to ensure compliance.

Job description

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Product Submissions and Registration

Job Category:

Professional

All Job Posting Locations:

• Raynham, Massachusetts, United States of America
• Warsaw, Indiana, United States of America
• West Chester, Pennsylvania, United States of America

Job Description:

About Orthopaedics

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that's reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems.

Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals.

Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

We are searching for the best talent for Senior Regulatory Affairs Specialist in Warsaw, IN, West Chester, PA , Raynham, MA.

Purpose:

The Senior Regulatory Affairs Specialist is responsible for regulatory activities to support new, modified and currently marketed medical devices in the DePuy Joint Reconstruction portfolio. This includes the preparation of regulatory documentation for submission to regulatory authorities (e.g., IDE, 510(k), PMA, Design Dossiers, and Technical Documentation) or internal regulatory assessment documentation. The Regulatory Project Leader is also responsible for the review and approval of all device labeling and product support information used in the promotion and educational activities of DePuy Synthes products for compliance to global regulations and company policies and procedures. In conjunction with other functions they support post market and provide lead external and Internal audits.

You will be responsible for:

• Prepares regulatory documentation for DePuy devices, including IDE, 510(k), PMA, Technical Files, Design Dossier, and Technical Documentation files for submission to regional Health authorities per FDA, MDD and MDR requirements. This includes the resolution of regulatory issues and questions from regulatory agencies during the pre-market product development phase.
• Provides support in preparation, writing and submission of global registration activities (Japan, China, Australia, NZ) requirements.
• Incumbent knows, understands, incorporates and follows all applicable laws and regulations relating to DePuy Synthes business activities and Policies and Procedures of the Health Care Compliance Program and Code of Conduct.
• Guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials.
• Review and approve changes with Product Lifecycle Management System to devices, design, packaging and labelling for Notified Body, FDA, and Global impact
• Review product labeling and product support information for currently marketed products to ensure that product information and claims are consistent with premarket clearances and approvals and in compliance with relevant regulations and guidan