Senior Regulatory Affairs Specialist, MedTech & Robotics

Antler; Raritan (NJ); On-site; USD 92,000 - 148,000; Full time

Benefits offered by this job

Pension plan

401(k) plan

Paid time off (vacation)

Job summary

Johnson & Johnson is seeking a Senior Regulatory Affairs Specialist to support the Instrumentation & Accessories team within OTTAVA robotics. This role focuses on achieving regulatory clearances for US and international markets, collaborating with engineering and clinical teams, and preparing submission-ready documentation.

The candidate will engage in strategy development, health authority communications, and cross-functional coordination to meet regulatory milestones across a robotics

Qualifications

• Bachelor's degree in science, engineering or related field.
• 4+ years regulatory affairs in medical devices; 3+ years with advanced degree.
• Experience with FDA submissions (510(k)) and global authorities.

Responsibilities

• Develop and implement regulatory strategies for new product clearances.
• Prepare, write, and file FDA submissions (510(k)) and global submissions.
• Coordinate with cross-functional teams to meet regulatory milestones.
• Ensure conformance with regulations in product development, labeling and claims.
• Assist in developing Regulatory Affairs processes.

Skills

Analytical Reasoning

Business Behavior

Business Writing

Communication

Confidentiality

Data Reporting

Detail-Oriented

Legal Support

Medicines and Device Development and &

Education

Bachelor's Degree in Science/Engineering

Advanced Degree preferred

Tools

Job description

Johnson & Johnson is seeking a Senior Regulatory Affairs Specialist to support the Instrumentation & Accessories team within OTTAVA robotics. This role focuses on achieving regulatory clearances for US and international markets, collaborating with engineering and clinical teams, and preparing submission-ready documentation.

The candidate will engage in strategy development, health authority communications, and cross-functional coordination to meet regulatory milestones across a robotics