Senior Regulatory Affairs Lead – MedTech Robotics

Brighter Signals; United States; On-site; USD 109,000 - 175,000; Full time

Benefits offered by this job

Vacation – 120 hours per calendar year

Sick time – 40 hours per calendar year

Holiday pay – 13 days/year

Parental Leave – 480 hours/year

Job summary

Johnson & Johnson is seeking a Senior Regulatory Affairs Program Lead for the Instrumentation & Accessories team under the OTTAVA robotics group. The role involves leading regulatory strategy development and execution for robotic instruments and accessories, with global submissions and health authority interactions.

Candidates should have 6+ years in medical device regulatory affairs and be able to travel up to 25%.

Qualifications

• Bachelor's degree in Science, Engineering, or related field.
• Regulatory Affairs experience in medical devices required.
• Experience with global regulatory submissions and health authorities.

Responsibilities

• Lead regulatory strategy development for robotic instruments and accessories.
• Prepare and file FDA submissions and global health authority documents.
• Coordinate with engineering and clinical teams throughout product development.
• Ensure regulatory compliance and communicate timelines.

Skills

Regulatory strategy

Regulatory submissions

Cross-functional collaboration

Global regulations

Regulatory feedback

Verbal communication

Written communication

Analytical skills

Problem solving

Travel up to 25%

Team collaboration

Regulatory milestones

Education

Bachelor's Degree

Advanced degree desired

Job description

Johnson & Johnson is seeking a Senior Regulatory Affairs Program Lead for the Instrumentation & Accessories team under the OTTAVA robotics group. The role involves leading regulatory strategy development and execution for robotic instruments and accessories, with global submissions and health authority interactions.

Candidates should have 6+ years in medical device regulatory affairs and be able to travel up to 25%.