Senior Regulatory Affairs Lead, MedTech Robotics (Remote)

Antler; Santa Clara (CA); Hybrid; USD 125,000 - 201,000; Full time

Benefits offered by this job

Vacation 120 hours

Parental Leave 480 hours

Job summary

Johnson & Johnson is seeking a Senior Regulatory Affairs Program Lead to drive regulatory strategy for OTTAVA robotics. You will collaborate with engineering and clinical teams to advance robotic instruments and accessories through global submissions and approvals.

The role requires guiding regulatory concerns across development stages, crafting submissions, and communicating timelines to ensure timely market access for innovative surgical solutions.

Qualifications

• Bachelor's degree required; advanced degree highly desired in science, engineering, or related field.
• Minimum 6+ years of regulatory affairs experience in medical devices (4+ with advanced degree).
• Experience with regulatory new product submissions and global health authorities.

Responsibilities

• Lead regulatory strategy development and execution for robotic instruments and accessories.
• Prepare and file FDA submissions and global health authority documents.
• Collaborate with engineering and clinical teams across product development stages.
• Communicate timelines, identify risks, and support regulatory milestones.

Skills

Regulatory strategy

Global submissions

Cross-functional collaboration

Regulatory expertise

Communication skills

Project leadership

Attention to detail

Education

Bachelor's Degree

Advanced Degree desirable

Job description

Johnson & Johnson is seeking a Senior Regulatory Affairs Program Lead to drive regulatory strategy for OTTAVA robotics. You will collaborate with engineering and clinical teams to advance robotic instruments and accessories through global submissions and approvals.

The role requires guiding regulatory concerns across development stages, crafting submissions, and communicating timelines to ensure timely market access for innovative surgical solutions.