Regulatory Affairs Lead, MedTech Robotics - Remote

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

Benefits offered by this job

Vacation & Leave benefits

Family & Parental leave

Sick & holiday time off

Comprehensive health benefits

Job summary

Johnson & Johnson seeks a Senior Regulatory Affairs Program Lead to support the OTTAVA robotics group within the Surgery division. The role focuses on regulatory strategy development and execution for robotic instruments and accessories, collaborating with engineering and clinical teams to support development stages and prepare submission-ready documentation.

Ideal candidates have extensive experience with medical device regulatory submissions, strong communication skills, and readiness to

Qualifications

• Bachelor's degree in Science, Engineering or related field required.
• 6+ years regulatory affairs in medical devices required (4+ with advanced degree).
• Experience with FDA submissions and global health authorities.
• Strong communication and project management skills.

Responsibilities

• Instills and drives a vibrant regulatory culture, working among cross functional groups as a teammate and collaborator.
• Applies strategic regulatory thinking along with technical expertise to develop and implement regulatory strategies for new product clearances and approvals.
• Prepares and submits regulatory information required to obtain global market access, including preparation, writing and filing of FDA submissions (e.g., Q-submissions, IDEs, De Novo, 510(k)s) and global health authorities’ submissions technical documents.
• Serves as a Regulatory Affairs subject matter expert on new product development and engineering design control teams.
• Proactively identify issues, effectively communicate timelines for project completion, and address complex issues that may impact registration status.
• Conduct regulatory evaluation of changes to devices in accordance with requirements of commercial/operating geography and generate the required regulatory submission (including Letters To File)
• Guides conformance with applicable regulations and guidance documents in product development, support of claims, content labeling, and promotional materials.
• Assists in the development of Regulatory Affairs processes.

Skills

Regulatory strategy

FDA submissions

Global regulatory

Cross-functional collaboration

Education

Bachelor's degree in Science/Engineering

Advanced degree preferred

Job description

Johnson & Johnson seeks a Senior Regulatory Affairs Program Lead to support the OTTAVA robotics group within the Surgery division. The role focuses on regulatory strategy development and execution for robotic instruments and accessories, collaborating with engineering and clinical teams to support development stages and prepare submission-ready documentation.

Ideal candidates have extensive experience with medical device regulatory submissions, strong communication skills, and readiness to