Senior Regulatory Affairs Lead – MedTech Robotic Surgery

Antler; Raritan (NJ); On-site; USD 109,000 - 175,000; Full time

Benefits offered by this job

Vacation

Sick time

Holiday pay

Parental Leave

Bereavement Leave

Volunteer Leave

Job summary

Johnson & Johnson is seeking a Senior Regulatory Affairs Program Lead to drive regulatory strategy and execution for robotic instruments and accessories within the OTTAVA robotics group. You will collaborate with engineering and clinical teams to support product development stages and health authority submissions.

The role prefers candidates near Cincinnati, OH, Santa Clara, CA, or Raritan, NJ, with remote options considered on a case-by-case basis. Up to 25% travel may be required.

Qualifications

• Bachelor's degree required; advanced degree highly desired.
• 6+ years of regulatory affairs experience within medical devices.
• Experience with medical device regulatory submissions.
• Track record of developing and driving regulatory strategies.
• Strong communication and collaboration with cross-functional partners.

Responsibilities

• Lead regulatory strategy development and execution for robotic instruments and accessories.
• Prepare and submit FDA submissions (Q-submissions, IDEs, De Novo, 510(k)s) and global health authorities’ documents.
• Collaborate with engineering and clinical teams throughout product development stages.
• Support health authority communications and regulatory milestones.
• Ensure conformance with applicable regulations and guidance documents; develop regulatory processes.

Skills

Regulatory strategy

FDA submissions

Cross-functional collaboration

Regulatory affairs

Attention to detail

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 robotic instruments and accessories within the OTTAVA robotics group. You will collaborate with engineering and clinical teams to support product development stages and health authority submissions.

The role prefers candidates near Cincinnati, OH, Santa Clara, CA, or Raritan, NJ, with remote options considered on a case-by-case basis. Up to 25% travel may be required.