Senior Regulatory Lead, MedTech Robotics (Remote)

Regulatory Jobs; Santa Clara (CA); Hybrid; USD 125,000 - 201,000; Full time

Benefits offered by this job

Pension plan

401(k) plan

Paid time off

Job summary

Johnson & Johnson is seeking a Senior Regulatory Affairs Program Lead to guide regulatory strategy for OTTAVA robotics. You will work with engineering and clinical teams to develop submissions, support health authority communications, and drive regulatory milestones across the US and international markets.

The role may require up to 10% travel and is based near Santa Clara, with remote options considered case-by-case.

Qualifications

• Bachelor’s degree required; advanced degree preferred.
• 6+ years of regulatory affairs in medical devices including software-enabled systems.
• Proven track record securing approvals (510(k), IDEs, De Novo).
• Strong cross-functional communication and strategic thinking.

Responsibilities

• Prepare and execute regulatory strategies for NPD and LCM projects.
• Lead regulatory submissions and FDA meeting preparations.
• Act as regulatory SME across product development and cross-functional teams.
• Support global health authority submissions and audits.
• Ensure regulatory documentation aligns with standards and timelines.

Skills

Regulatory strategy

Cross-functional collaboration

Regulatory submissions

Education

Bachelor's degree

Advanced degree

Tools

Regulatory software tools

Job description

Johnson & Johnson is seeking a Senior Regulatory Affairs Program Lead to guide regulatory strategy for OTTAVA robotics. You will work with engineering and clinical teams to develop submissions, support health authority communications, and drive regulatory milestones across the US and international markets.

The role may require up to 10% travel and is based near Santa Clara, with remote options considered case-by-case.