Senior Regulatory Affairs Program Lead (MedTech)

Location: United States; preference for candidates within commuting distance of Cincinnati, Ohio, Santa Clara, California, or Raritan, New Jersey; remote options considered case by case. Up to 25% travel required.

Salary: $109,000–$174,800 annually; Bay Area salary range: $125,000–$201,250 annually.

Company

Johnson & Johnson MedTech develops surgical technologies and healthcare solutions, including robotic instruments and accessories through the OTTAVA robotics group.

What you will do

• Develop and execute regulatory strategies for new product clearances and approvals.
• Prepare, author, and submit FDA filings, including Q-submissions, IDEs, De Novo submissions, and 510(k)s.
• Prepare technical documentation for global health authority submissions and support health authority communications.
• Provide regulatory expertise to product development and engineering design control teams, including reviews of specifications, testing, risk management, and submission documentation.
• Evaluate device changes, regulatory requirements, claims, labeling, and promotional materials across operating geographies.
• Identify regulatory risks, communicate project timelines, resolve complex issues, and support the development of Regulatory Affairs processes.

Requirements

• Bachelor’s degree in science, engineering, or a related field required; an advanced degree is highly desired.
• At least 6 years of related Regulatory Affairs experience in medical devices, or 4 years with an advanced degree.
• Experience with medical device regulatory submissions and developing regulatory strategies.
• Knowledge of global product registration requirements and experience with health authority meetings or interactions.
• Experience with medical device software guidance, IEC 60601, sterilization, biocompatibility, and reprocessing requirements and their submission documentation.
• Strong communication, analytical, organizational, prioritization, and problem-solving skills.

Culture & Benefits

• Cross-functional collaboration with engineering, clinical, and global regulatory colleagues.
• Retirement plan, pension, and 401(k) savings plan eligibility.
• Vacation, sick time, holidays, personal and family time, parental leave, caregiver leave, bereavement leave, volunteer leave, and military spouse time-off benefits.
• Inclusive employment environment and interview accommodations for applicants with disabilities.