Senior Regulatory Affairs Program Lead, Robotic Surgery (Remote)

Johnson & Johnson MedTech; Cincinnati (OH); Hybrid; USD 109,000 - 175,000; Full time

Benefits offered by this job

Vacation time

Sick time

Holiday pay

Parental Leave

Bereavement Leave

Volunteer Leave

Military Spouse Time-Off

Job summary

Johnson & Johnson is seeking a Senior Regulatory Affairs Program Lead for the OTTAVA robotics group. The role focuses on regulatory strategy for robotic instruments and accessories, partnering with engineering and clinical teams to advance development and submissions.

Preference is for candidates near Cincinnati, OH, Santa Clara, CA, or Raritan, NJ, with remote options considered case-by-case. Up to 25% travel may be required.

Qualifications

• Minimum of a Bachelor’s Degree required; advanced degrees preferred in science, engineering, or related field.
• Minimum of 6+ years of related Regulatory Affairs experience in Medical Devices.
• Experience with medical device regulatory new product submissions.
• Strong written and verbal communication with cross-functional partners.

Responsibilities

• Lead regulatory strategy development and execution for robotic instruments and accessories.
• Collaborate with engineering and clinical teams across development stages.
• Prepare, write, and file FDA submissions and global health authority documents.
• Provide regulatory feedback on specifications, testing, risk management and documentation.
• Identify issues early and communicate timelines for project completion.
• Regulatory evaluation of device changes and prepare required submissions.

Skills

Analytical Reasoning

Business Writing

Coaching

Collaboration

Communication

Problem Solving

Regulatory Affairs Management

Regulatory Compliance

Regulatory Development

Regulatory Environment

Regulatory Reporting

Risk Assessments

Strategic Thinking

Education

Bachelor's Degree

Advanced Degree

Job description

Johnson & Johnson is seeking a Senior Regulatory Affairs Program Lead for the OTTAVA robotics group. The role focuses on regulatory strategy for robotic instruments and accessories, partnering with engineering and clinical teams to advance development and submissions.

Preference is for candidates near Cincinnati, OH, Santa Clara, CA, or Raritan, NJ, with remote options considered case-by-case. Up to 25% travel may be required.