Senior Regulatory Affairs Specialist (MedTech)

Location: Cincinnati, Ohio; Santa Clara, California; Raritan, New Jersey; or Remote (US). Preference is given to candidates within commuting distance of the listed offices, while remote work may be considered case by case. Up to 25% travel is required.

Base pay: $92,000–$148,350 annually. Bay Area range: $106,000–$170,200 annually.

Company

Johnson & Johnson MedTech develops surgical technologies and healthcare solutions, including robotics, instruments, and accessories.

What you will do

• Develop and implement regulatory strategies for new medical device clearances and approvals.
• Prepare, write, and file FDA 510(k) submissions and technical documents for global health authorities.
• Support robotics, instruments, and accessories through product development and generate submission-ready documentation.
• Identify regulatory issues, communicate project timelines, and address risks that may affect registration status.
• Guide compliance with regulations and guidance for product development, claims, labeling, and promotional materials.
• Collaborate with engineering, clinical, and global colleagues and support regulatory process development.

Requirements

• Bachelor’s degree in science, engineering, or a related field is required; an advanced degree is highly desired.
• At least 4 years of relevant Regulatory Affairs experience in medical devices is required, or 3 years with an advanced degree.
• Experience with new product regulatory submissions for medical devices is required.
• Demonstrated ability to develop and implement regulatory strategies and assess the business impact of regulatory changes.
• Strong written and verbal communication, organization, attention to detail, prioritization, and collaboration skills.
• Availability for up to 25% travel and, for office-based candidates, commuting distance to Cincinnati, Santa Clara, or Raritan.

Nice to have

• Experience with health authority meetings and interactions.
• Experience with medical device software guidance, IEC 60601, sterilization, biocompatibility, and reprocessing requirements and submission documentation.

Culture & Benefits

• Inclusive work environment focused on individual dignity, diversity, and merit.
• Eligibility for pension and 401(k) savings plans.
• Vacation, sick time, holiday pay, work and family time, parental leave, caregiver leave, bereavement leave, volunteer leave, and military spouse time-off benefits.