Senior Regulatory Affairs Lead - MedTech Devices

Brighter Signals; West Chester (Chester County); On-site; USD 79,000 - 128,000; Full time

Job summary

Johnson & Johnson is seeking a Senior Regulatory Affairs Specialist to support regulatory activities for DePuy Orthopaedics devices. You will prepare regulatory documentation (IDE, 510(k), PMA, Design Dossiers) for submission to FDA and global authorities, and ensure labeling and claims comply with approvals.

You will lead regulatory efforts across multiple regions, monitor evolving MDR/QSR standards, and contribute to post-market surveillance and audits.

Qualifications

• Minimum of 2 years plus prior regulatory affairs or medical device experience.
• Knowledge of U.S. FDA and EU Medical Device Regulations MDR (and previous MDD).
• Familiarity with electronic submission preparation is a plus.
• Experience with orthopedic implants is a plus.

Responsibilities

• Prepare regulatory documentation for DePuy devices (IDE, 510(k), PMA, Technical Files, Design Dossier) for regulatory authorities.
• Support global registration activities (Japan, China, Australia, NZ).
• Ensure compliance with Health Authority regulations and company policies.
• Guide conformance with product development, labeling, and promotional materials.
• Review and approve labeling and product support information for regulatory compliance.
• Maintain up-to-date knowledge of FDA QSR, ISO 13485, and MDR requirements.
• Perform other duties as assigned.

Skills

Regulatory affairs

Medical devices

FDA regulations

EU MDR

Submission management

Communication skills

Attention to detail

Education

BA/BS degree

Job description

Johnson & Johnson is seeking a Senior Regulatory Affairs Specialist to support regulatory activities for DePuy Orthopaedics devices. You will prepare regulatory documentation (IDE, 510(k), PMA, Design Dossiers) for submission to FDA and global authorities, and ensure labeling and claims comply with approvals.

You will lead regulatory efforts across multiple regions, monitor evolving MDR/QSR standards, and contribute to post-market surveillance and audits.