Senior Regulatory Program Lead - Robotic Medical Systems (Remote)

Johnson & Johnson Innovative Medicine; United States; Remote; USD 125,000 - 201,000; Full time

Benefits offered by this job

Remote work option

Pension plan

401(k) plan

Vacation 120 hours/year

Sick time 40–56 hours/year

Holiday pay

Job summary

Johnson & Johnson Innovative Medicine is seeking a Senior Regulatory Affairs Program Lead to guide OTTAVA robotics regulatory strategy and execution in the US and internationally. You will partner with engineering and clinical teams to drive submissions and health authority communications.

This role offers remote options within the US, with preference for candidates near Santa Clara, CA and occasional travel up to 10%.

Qualifications

• Minimum of a Bachelor's degree; advanced degree strongly preferred.
• At least 6+ years regulatory affairs in medical devices with software-enabled systems.
• Track record of securing approvals (510(k), IDE, De Novo).
• Strong collaboration and cross-functional influence; able to navigate ambiguity.

Responsibilities

• Develop regulatory strategy for NPD and LCM projects.
• Lead cross-functional regulatory activities across development, submission and approvals.
• Provide expert regulatory input for specifications, testing, risk, labeling and submissions.
• Prepare FDA submissions (Q-submissions, IDEs, De Novo, 510(k)) and lead FDA meeting prep.
• Support global health authority submissions and regulatory changes as needed.
• Support audits and health authority communications.

Skills

Regulatory strategy

FDA submissions

Cross-functional collaboration

Regulatory Compliance

Regulatory Reporting

Product Licensing

Regulatory Development

Regulatory Environment

Strategic Thinking

Analytical Reasoning

Business Writing

Problem Solving

Public Policies

Regulatory Affairs Management

Risk Assessments

Education

Bachelor's degree

Advanced degree preferred

Tools

IEC 60601

ISO 10993-1

FDA software regulatory

Job description

Johnson & Johnson Innovative Medicine is seeking a Senior Regulatory Affairs Program Lead to guide OTTAVA robotics regulatory strategy and execution in the US and internationally. You will partner with engineering and clinical teams to drive submissions and health authority communications.

This role offers remote options within the US, with preference for candidates near Santa Clara, CA and occasional travel up to 10%.