Senior Regulatory Affairs Lead, MedTech Robotics

Johnson & Johnson MedTech; Raritan (NJ); On-site; USD 109,000 - 175,000; Full time

Benefits offered by this job

Vacation time

Sick leave

Floating holidays

Parental leave

Bereavement leave

Job summary

Johnson & Johnson MedTech seeks a Senior Regulatory Affairs Program Lead for the OTTAVA robotics group. Join a team delivering regulatory strategy and submissions for robotic instruments, driving global market access and health authority communications.

You will collaborate with engineering and clinical teams, lead regulatory milestones, and manage submission documents across geographies while travel up to 25% is expected.

Qualifications

• Bachelor's degree in Science, Engineering or related field.
• Minimum of 6+ years regulatory affairs in medical devices.
• Experience with medical device regulatory submissions required.
• Track record of developing and implementing regulatory strategies.
• Global regulatory requirements knowledge and impact assessment.
• Excellent verbal and written communication; strong attention to detail.

Responsibilities

• Lead regulatory strategy development and execution for robotic instruments and accessories.
• Prepare and submit FDA and global regulatory submissions (Q-submissions, IDEs, De Novo, 510(k)s).
• Collaborate with engineering and clinical teams across product development stages.
• Maintain timely regulatory submissions and health authority communications.
• Identify and address issues impacting registration status.
• Ensure conformance with regulations in product development, labeling, and promotional materials.

Skills

Regulatory strategy

FDA submissions

Global registrations

Cross-functional collaboration

Regulatory intelligence

Regulatory milestones

Communication skills

Project leadership

Education

Bachelor's Degree

Advanced Degree

Job description

Johnson & Johnson MedTech seeks a Senior Regulatory Affairs Program Lead for the OTTAVA robotics group. Join a team delivering regulatory strategy and submissions for robotic instruments, driving global market access and health authority communications.

You will collaborate with engineering and clinical teams, lead regulatory milestones, and manage submission documents across geographies while travel up to 25% is expected.