Senior Regulatory Program Lead - Medical Devices & Robotics

Antler; Cincinnati (OH); Hybrid; USD 109,000 - 175,000; Full time

Benefits offered by this job

Vacation 120 hours/year

Floating holidays 13 days/year

Parental leave 480 hours/year

401(k) retirement plan

Job summary

Johnson & Johnson is seeking a Senior Regulatory Affairs Program Lead to support Robotics & Digital Solutions. The role targets Cincinnati, OH (or Santa Clara, CA) with a hybrid schedule (3 days in-office) and up to 25% travel.

You will drive regulatory strategy, develop submissions, and liaise with health authorities worldwide. You will collaborate with engineering and clinical teams, ensure timely documentation, and lead complex regulatory milestones for robotic instruments and

Qualifications

• Bachelor's degree in Science or Engineering or related field.
• Minimum 6+ years of regulatory affairs experience in Medical Devices.
• Experience with FDA submissions (Q-submissions, IDEs, De Novo, 510(k)).

Responsibilities

• Lead regulatory strategy development and execution for robotic instruments and accessories.
• Prepare and file regulatory submissions and coverage for global markets.
• Collaborate with engineering and clinical teams across product development.
• Communicate with health authorities and manage project timelines.
• Guide conformance with regulations in product development and labeling.

Skills

Regulatory strategy

Cross-functional collaboration

Regulatory submissions

Communication

Attention to detail

Travel up to 25%

Education

Bachelor's Degree in Science/Engineering

Advanced Degree preferred

Job description

Johnson & Johnson is seeking a Senior Regulatory Affairs Program Lead to support Robotics & Digital Solutions. The role targets Cincinnati, OH (or Santa Clara, CA) with a hybrid schedule (3 days in-office) and up to 25% travel.

You will drive regulatory strategy, develop submissions, and liaise with health authorities worldwide. You will collaborate with engineering and clinical teams, ensure timely documentation, and lead complex regulatory milestones for robotic instruments and