Regulatory Affairs Analyst

Johnson & Johnson Johnson & Johnson · Pharma · Ciudad Juarez, Chihuahua, Mexico

The Regulatory Affairs Analyst role at Johnson & Johnson supports regulatory activities for medical device approvals and clearances in the US and European markets. Responsibilities include preparing, submitting, tracking, and archiving official documents, collaborating with global regulatory affairs partners and functional teams, and ensuring compliance with international regulations.

What you'd actually do

  1. Supports the preparation, compilation of regulatory submissions of technical and scientific medical device product information to US FDA, EU Notified Bodies, and other government regulatory agencies and assists in responding to regulatory authority queries and deficiency letters.
  2. Completes assignments for the creation and maintenance of regulatory documents and records related to FDA submissions, Technical Documentation, Design Dossiers, Letters to File, regulatory impact assessment of changes, and other regulatory documents for medical devices, including US Class II and III devices and EU MDR Class III devices.
  3. Reviews proposed labelling, packaging, and promotional materials to evaluate conformance to applicable global market regulations.
  4. Attends regular meetings with project teams for product development and product changes, communicating applicable regulatory requirements and activities needed to gain and maintain regulatory approval in various markets.
  5. Collaborates with other Regulatory team members in preparing and documenting communications (verbal and written) with FDA, EU Notified Bodies, and other external regulatory agencies

Skills

Required

  • Regulatory affairs
  • Medical device regulations
  • FDA submissions
  • EU MDR
  • Technical documentation
  • Compliance

Nice to have

  • Global regulatory affairs
  • Research and Development collaboration
  • Quality assurance
  • Supply chain collaboration
  • Marketing collaboration