Job Title: Regulatory Affairs Specialist (EES) – MedTech Surgery
Function: Regulatory Affairs Group
Sub Function: Regulatory Affairs
Category: Analyst, Regulatory Affairs (P4 – E24)
Work Pattern: Hybrid Work (3 days/week onsite)
Location: Cincinnati, OH or Raritan, NJ, United States
Requisition Number: R-013232
Date Posted: May 12, 2025
Application Deadline: May 26, 2025 (subject to extension)
Job Summary:
Johnson & Johnson is seeking a Regulatory Affairs Specialist for the Ethicon Endo Surgery (EES) division within its MedTech Surgery segment. The position requires a proactive regulatory professional with experience in healthcare product compliance to support 510(k) registrations and significant change supplements.
Key Responsibilities:
Develop and execute regulatory strategies to support EES products.
Ensure compliance with applicable regulations and interpretations.
Prepare responses to regulatory agency questions and correspondence.
Compile information and documentation for regulatory submissions.
Offer solutions to regulatory problems with moderate scope/complexity.
Engage with regulatory bodies/distributors for approvals and data requests.
Review and advise on product labeling to ensure regulatory compliance.
Represent Regulatory Affairs on cross-functional project teams.
Provide support during internal and external audits.
Contribute to best practices for Regulatory Affairs processes and systems.
Communicate relevant issues or opportunities to upper management.
Ensure strict adherence to all company and regulatory requirements.
Qualifications:
Education:
Bachelor's degree required (Physical Sciences, Biomedical Engineering, Medical/Scientific Writing, or related fields).
Advanced Degree strongly preferred.
Experience:
Minimum 3+ years in Regulatory Affairs or a closely related field within a regulated industry (2+ years with advanced degree).
Medical device industry experience and prior submission experience are highly desirable.
Skills & Knowledge:
Familiarity with US and international health product regulations.
Strong problem-solving, decision-making, and project execution abilities.
Ability to work independently and collaboratively across teams.
Excellent written and verbal communication skills.
Ability to represent Regulatory Affairs internally and externally.
Leadership & Behavioral Competencies:
Connect: Foster internal collaboration and build strong networks.
Shape: Challenge the status quo and adapt to regulatory changes.
Lead: Value diverse perspectives and encourage innovative thinking.
Deliver: Manage priorities effectively and ensure timely submissions.
Compensation & Benefits:
Base Salary Range: $74,000 – $119,600 (based on factors like experience and location).
Bonus Eligibility: Annual performance-based cash bonus.
Benefits: Medical, dental, vision, life insurance, short/long-term disability, accident & legal insurance, pension plan, 401(k), and generous paid time off (vacation, sick leave, holidays, and family time).
Additional Information:
This is a Hybrid Role – candidates must be available to work 3 days per week in-office (Cincinnati or Raritan). Remote work is not an option.
Johnson & Johnson is committed to equal opportunity employment and provides accommodations for individuals with disabilities.
For accommodation requests, contact: ra-employeehealthsup@its.jnj.com
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