Senior Regulatory Affairs Lead, MedTech Submissions

6029-MEDICAL DEVICE BUSINESS SERVICES, INC. Legal Entity; Irvine (CA); On-site; USD 109,000 - 175,000; Full time

Job summary

Johnson & Johnson in Irvine, CA seeks a Senior Regulatory Affairs Specialist to lead regulatory strategy, submissions, and global registrations for medical devices. You will partner with product teams to ensure timely regulatory milestones and compliance for new and existing products.

Ideal candidates have 6+ years in medical device regulatory affairs, strong communication skills, and experience with FDA and international submissions. Significant travel may be required.

Qualifications

• Bachelor's degree required; advanced degree highly desired; RAC certification a plus.

Responsibilities

• Provide input and guidance during New Product Development and Lifecycle Management projects, including regulatory strategy and supporting evidence.
• Define, gather and assemble information necessary for submissions in accordance with regulations and guidelines.
• Prepare responses to regulatory agencies' questions and other correspondence to resolve post-submission queries.
• Communicate with FDA and Notified Body reviewers to identify pre-submission requirements and align submission strategy.
• Lead the submission of licenses and authorizations for existing products and support international registrations.
• Guide conformance with regulations in cross-functional projects and labeling development.

Skills

Regulatory strategy

Regulatory submissions

FDA interactions

Cross-functional collaboration

Education

Bachelor's Degree

Advanced Degree

RAC certification

Job description

Johnson & Johnson in Irvine, CA seeks a Senior Regulatory Affairs Specialist to lead regulatory strategy, submissions, and global registrations for medical devices. You will partner with product teams to ensure timely regulatory milestones and compliance for new and existing products.

Ideal candidates have 6+ years in medical device regulatory affairs, strong communication skills, and experience with FDA and international submissions. Significant travel may be required.