Senior Regulatory Affairs Program Lead, Robotics & MedTech

6267-Auris Health Inc. Legal Entity; Cincinnati (OH); On-site; USD 109,000 - 175,000; Full time

Benefits offered by this job

401(k) plan

Vacation

Parental Leave

Volunteer Leave

Job summary

Johnson & Johnson is seeking a Senior Regulatory Affairs Program Lead to support the OTTAVA robotics group in Cincinnati. You will drive regulatory strategy for robotic instruments and accessories, work with engineering and clinical teams on development and submissions, and manage global health authority filings.

The role requires advanced knowledge of medical device regulations, strong communication, and up to 25% travel. Remote options may be considered case-by-case.

Qualifications

• Minimum of a Bachelor's Degree in a science, engineering or related field.
• 5+ years of regulatory affairs experience in medical devices; advanced degree may reduce experience needs.

Responsibilities

• Lead regulatory strategy development and execution for robotic instruments and accessories.
• Collaborate with engineering and clinical teams on product development and submissions.
• Prepare FDA submissions (Q-submissions, IDEs, De Novo, 510(k)) and global filings.
• Engage in health authority meetings and communications.
• Develop and implement regulatory submission plans and timelines.
• Travel up to 25% as required.

Skills

Analytical Reasoning

Business Writing

Collaboration

Communication

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 to support the OTTAVA robotics group in Cincinnati. You will drive regulatory strategy for robotic instruments and accessories, work with engineering and clinical teams on development and submissions, and manage global health authority filings.

The role requires advanced knowledge of medical device regulations, strong communication, and up to 25% travel. Remote options may be considered case-by-case.