Job Title:
Senior Regulatory Affairs Program Lead – Mentor, LLC
Function:
Regulatory Affairs Group
Sub Function:
Regulatory Affairs
Category:
Senior Analyst, Regulatory Affairs (P6)
Location:
Irving, Texas, United States of America
Date Posted:
April 23, 2025
Requisition Number:
R-009475
Work Pattern:
Hybrid Work
Closing Date:
May 02, 2025 (May be extended)
Description:
Johnson & Johnson is seeking a Senior Regulatory Affairs Program Lead for its Mentor business unit, located in Irving, TX. This role is responsible for developing and executing global regulatory strategies focused on life cycle management (LCM) and product modifications. It involves cross-functional collaboration with R&D, Supply Chain, Quality, Marketing, and other stakeholders to support regulatory submissions and ensure product compliance.
Key Responsibilities:
Develop and implement regulatory strategies to support product maintenance, modified product launches, and compliance.
Evaluate product design, labeling, and manufacturing changes for regulatory impact.
Prepare and submit regulatory documents (510(k), PMA, CE Mark, etc.).
Partner with cross-functional teams to gather data for international and U.S. submissions.
Respond to regulatory agencies and address compliance issues.
Provide regulatory support during audits.
Assist in defining best practices for regulatory processes.
Serve as the Regulatory Affairs representative on project teams.
Qualifications:
Bachelor’s degree required (Advanced degree strongly preferred).
Minimum 6 years of regulatory affairs or related experience (4 years with advanced degree).
RAC Certification highly desirable.
Strong preference for candidates with medical device regulatory experience.
Experience preparing U.S. and international regulatory submissions (510(k), PMA, CE Mark).
Excellent project management, communication, and presentation skills.
Experience with regulatory interactions and agency communications.
Additional Information:
This is an onsite position based at the Irving, TX manufacturing facility.
Minimal travel required.
Johnson & Johnson is an Equal Opportunity Employer.
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