Senior Regulatory Affairs Specialist - Robotics/MedTech

Johnson & Johnson Co.; Cincinnati (OH); Hybrid; USD 92,000 - 148,000; Full time

Job summary

Johnson & Johnson is seeking a Senior Regulatory Affairs Specialist to support the Instrumentation & Accessories team under OTTAVA Robotics. You will work with engineering and clinical teams to prepare regulatory submissions and drive global market access for robotics, instruments and accessories.

Preferred candidates reside within commuting distance of Cincinnati, OH, Santa Clara, CA, or Raritan, NJ, with remote options considered case-by-case. Travel up to 25% may be required.

Qualifications

• Bachelor's degree required; advanced degree preferred.
• Minimum 4+ years of regulatory affairs in medical devices required.
• Experience with regulatory submissions for new products is required.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Applies strategic regulatory thinking to implement plans for new product clearances and approvals.
• Prepare, write, and file FDA submissions including 510(k)s and global health authorities’ documents.
• Identify issues early, communicate timelines, and manage registration status risk.
• Guide conformance to regulations in product development, labeling and promotional materials.
• Assist in developing Regulatory Affairs processes.

Skills

Analytical Reasoning

Regulatory Writing

Cross-functional Collaboration

Communication

Regulatory Strategy

Presentation

Education

Bachelor's Degree

Advanced Degree

Tools

FDA Submissions

Job description

Johnson & Johnson is seeking a Senior Regulatory Affairs Specialist to support the Instrumentation & Accessories team under OTTAVA Robotics. You will work with engineering and clinical teams to prepare regulatory submissions and drive global market access for robotics, instruments and accessories.

Preferred candidates reside within commuting distance of Cincinnati, OH, Santa Clara, CA, or Raritan, NJ, with remote options considered case-by-case. Travel up to 25% may be required.