Senior Regulatory Affairs Program Lead (OTTAVA) - MedTech Surgery

Location: Remote within the United States or Santa Clara, California; preference for candidates within commuting distance of Santa Clara, with remote work considered case by case and subject to approval. Up to 10% travel may be required.

Salary: $125,000–$201,250 base pay annually.

Company

Johnson & Johnson MedTech develops innovative medical technologies and surgical solutions, including robotic systems and less invasive treatments.

What you will do

• Develop and execute regulatory strategies for new product development and lifecycle management projects.
• Lead regulatory activities across product development, submissions, approvals, and sustaining activities.
• Review specifications, device testing, risk management, labeling, and other documentation for software-enabled electromechanical devices.
• Prepare, write, and file FDA submissions, including Q-submissions, IDEs, De Novo applications, and 510(k)s.
• Lead FDA meeting preparation and support communications and technical submissions to global health authorities.
• Support change assessments, Letters to File, registrations, renewals, and audits.

Requirements

• Bachelor’s degree required; an advanced degree is strongly preferred.
• At least 6 years of regulatory affairs experience in medical devices, including software-enabled systems.
• Proven experience securing regulatory approvals such as 510(k)s, IDEs, and De Novo applications.
• Experience supporting the US market and evaluating regulatory requirements and changes.
• Strong strategic thinking, problem-solving, written communication, and cross-functional collaboration skills.
• Experience leading multiple complex projects and synthesizing regulations, guidances, and regulatory trends.

Nice to have

• Experience with health authority meetings and meeting preparation.
• Experience with vision systems, robotics, and connected medical platforms.
• Experience with the IEC 60601 series and ISO 10993-1.
• Strong knowledge of FDA software and cybersecurity regulatory requirements.

Culture & Benefits

• Inclusive work environment guided by the company’s Credo and equal employment opportunity principles.
• Retirement pension and 401(k) savings plans.
• Vacation, sick time, holidays, personal and family time, parental leave, bereavement leave, caregiver leave, volunteer leave, and military spouse time-off benefits.
• Work supporting surgical technologies intended for surgeons, healthcare professionals, and patients worldwide.