Orthopaedics Regulatory Affairs Specialist II

Brighter Signals; Warsaw (IN); On-site; USD 76,000 - 122,000; Full time

Job summary

Johnson & Johnson’s Orthopaedics Regulatory Affairs team in Warsaw, IN is seeking a Regulatory Affairs Specialist II. You will execute regulatory activities to support marketed devices and new product development across DePuy Synthes lines.

Join a global leader committed to innovation, quality, and patient safety. You will author regulatory documents, coordinate submissions with FDA and international authorities, and drive compliance across projects.

Qualifications

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

Responsibilities

• Prepare regulatory documents for DePuy devices (IDE, 510(k), PMA, Technical File) for regional authorities.
• Assist preparation of documents for rest-of-world registrations (EU CE).
• Review engineering changes and prepare internal regulatory assessments.
• Assess regulatory impact of manufacturing changes on licenses.
• Review labeling and product information for compliance.
• Provide guidance to project teams on regulatory pathways and submissions.
• Maintain knowledge of FDA QSR, ISO 13485, MDR/MDD requirements.
• Escalate regulatory issues to management and communicate across teams.
• If supervising, ensure team compliance with guidelines.
• Ensure compliance with applicable laws and company policies.
• Perform other duties as required.

Skills

Regulatory Affairs

Regulatory submissions

Regulatory knowledge

Documentation

Education

BA/BS degree

Job description

Johnson & Johnson’s Orthopaedics Regulatory Affairs team in Warsaw, IN is seeking a Regulatory Affairs Specialist II. You will execute regulatory activities to support marketed devices and new product development across DePuy Synthes lines.

Join a global leader committed to innovation, quality, and patient safety. You will author regulatory documents, coordinate submissions with FDA and international authorities, and drive compliance across projects.