Senior Regulatory Affairs Lead – MedTech Surgery (Remote)

Johnson & Johnson MedTech; Santa Clara (CA); Hybrid; USD 109,000 - 175,000; Full time

Benefits offered by this job

Vacation 120 hours/year

Sick time 40 hours/year (Colorado 48,;

Holiday pay 13 days/year

Parental Leave

Bereavement Leave

Caregiver Leave

Volunteer Leave

Job summary

Johnson & Johnson MedTech is seeking a Senior Regulatory Affairs Program Lead for the OTTAVA robotics team. The role supports US and international regulatory goals, partnering with engineering and clinical teams to author submissions and manage health authority communications.

Remote options may be considered for the right candidate, with travel up to 25%. The position requires a strong track record in regulatory strategy, submissions, and cross-functional collaboration across medical devices,

Qualifications

• Bachelor's degree required; advanced degree highly desired.
• Minimum of 6+ years of regulatory affairs experience in medical devices.
• Experience with medical device regulatory submissions required.
• Proven track record developing and implementing regulatory strategies.
• Working knowledge of global regulatory requirements and health authority processes.
• Excellent verbal and written communication; strong cross-functional collaboration.
• Position requires travel up to 25%.
• Experience with medical device software guidance, IEC 60601, sterilization, biocompatibility, and reprocessing documentation.

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, IDEs, De Novo, 510(k)).
• Acts as regulatory expert in new product development and engineering design control with compliance reviews.
• Identifies issues early and communicates timelines for project milestones.
• Guides conformance with regulations in product development, labeling, and promotions.

Skills

Regulatory Strategy

FDA Submissions

Global Regulatory

Cross-functional Collaboration

Communication Skills

Travel Willingness

Health Authority Meetings

IEC 60601/biocompatibility

Education

Bachelor's Degree

Advanced Degree

Job description

Johnson & Johnson MedTech is seeking a Senior Regulatory Affairs Program Lead for the OTTAVA robotics team. The role supports US and international regulatory goals, partnering with engineering and clinical teams to author submissions and manage health authority communications.

Remote options may be considered for the right candidate, with travel up to 25%. The position requires a strong track record in regulatory strategy, submissions, and cross-functional collaboration across medical devices,