Senior Regulatory Lead, MedTech Robotics (Remote)

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

Benefits offered by this job

Vacation time 120 hours/yr

Sick time 40–56 hours/yr

Holiday pay 13 days/yr

Parental leave 480 hours/yr

Bereavement leave 240 hours/yr

Job summary

Johnson & Johnson is seeking a Senior Regulatory Affairs Program Lead to drive regulatory strategy and execution for the OTTAVA robotics portfolio, collaborating closely with engineering and clinical teams. The role focuses on US and international submissions, including FDA filings, to enable timely market access.

The candidate will work across global health authorities, coordinate with product development, and support strategic regulatory initiatives, with up to 25% travel.

Qualifications

• Bachelor's degree required; advanced degree preferred.
• 6+ years regulatory affairs experience in medical devices; regulatory submissions experience required.
• Excellent written and verbal communication with cross-functional partners.

Responsibilities

• Lead regulatory strategy development and execution for robotic instruments and accessories.
• Prepare, write and file FDA submissions (Q-submissions, IDEs, De Novo, 510(k)) and global health authority submissions.
• Support health authority communications and regulatory submissions across multiple geographies.
• Collaborate with engineering and clinical teams to align development with regulatory requirements.
• Identify and escalate regulatory risks; communicate timelines for project milestones.

Skills

Regulatory strategy

FDA submissions

Cross-functional

Medical devices

Global regulations

Communication

Education

Bachelor's degree

Advanced degree

Job description

Johnson & Johnson is seeking a Senior Regulatory Affairs Program Lead to drive regulatory strategy and execution for the OTTAVA robotics portfolio, collaborating closely with engineering and clinical teams. The role focuses on US and international submissions, including FDA filings, to enable timely market access.

The candidate will work across global health authorities, coordinate with product development, and support strategic regulatory initiatives, with up to 25% travel.