Remote Senior Regulatory Affairs Lead - MedTech Surgery

Johnson & Johnson MedTech; Cincinnati (OH); Hybrid; USD 109,000 - 175,000; Full time

Benefits offered by this job

Vacation time

Sick leave

Holiday pay

Parental leave

Volunteer time off

Job summary

Johnson & Johnson is seeking a Senior Regulatory Affairs Program Lead to support OTTAVA robotics across US and international markets. This role will lead regulatory strategy development and submission execution for robotic instruments and accessories, working with engineering and clinical teams.

Prefer candidates near Cincinnati or commutable locations; remote options may be considered. Some travel up to 25% is required while enabling global market access and regulatory submissions.

Qualifications

• Bachelor's degree in Science, Engineering or related field is required.
• Advanced degree is highly desired for this role.
• 6+ years of regulatory affairs experience within medical devices.
• Experience with global regulatory submissions (FDA, IDEs, 510(k), De Novo).
• Strong communication and cross-functional collaboration skills.
• Willingness to travel up to 25%.

Responsibilities

• Instills and drives a vibrant regulatory culture across cross-functional groups.
• Develops and implements regulatory strategies for new product clearances and approvals.
• Prepares and submits regulatory information for global market access (FDA submissions, etc.).
• Serves as regulatory subject matter expert on product development and design control teams.
• communicates timelines and addresses issues impacting registration status.
• Evaluates regulatory changes and assesses business impact.
• Guides conformance with regulations in labeling and promotional materials.
• Assists in developing Regulatory Affairs processes.

Skills

Regulatory strategy

Regulatory submissions

Medical devices

Global regulations

Communication

Travel 25%

Education

Bachelor's degree

Advanced degree desired

Job description

Johnson & Johnson is seeking a Senior Regulatory Affairs Program Lead to support OTTAVA robotics across US and international markets. This role will lead regulatory strategy development and submission execution for robotic instruments and accessories, working with engineering and clinical teams.

Prefer candidates near Cincinnati or commutable locations; remote options may be considered. Some travel up to 25% is required while enabling global market access and regulatory submissions.