Johnson & Johnson-posted about 1 year ago
Full-time • Senior
Plymouth, MN
Chemical Manufacturing

The Associate Director of Regulatory Affairs at Johnson & Johnson is responsible for ensuring compliance with global regulations and managing the regulatory processes for medical devices. This role involves developing strategies for product registration, overseeing documentation for regulatory submissions, and fostering a regulatory culture within the organization. The position requires collaboration with various teams to ensure adherence to regulatory standards and to facilitate timely approvals for products.

  • Ensure compliance with global regulations and regulating agencies.
  • Interpret the intent of regulations and policies and provide information to project teams and management.
  • Instill and drive a regulatory culture; establish and support policies and standards for new products.
  • Develop and execute worldwide strategies for product registration, notification, or pre-market approval requirements.
  • Partner with WW Clinical Operations to develop clinical strategies and ensure compliance with regulations for conducting clinical trials worldwide.
  • Manage the generation of documentation for submission to worldwide governmental regulatory agencies to secure product approvals.
  • Develop US IDE/510K/ and PMA submissions for class II and III medical devices, and EU Design Dossiers and Technical Files.
  • Conduct submission negotiations with the FDA, including pre-submission identification of requirements and strategy.
  • Maintain proficiency on regulatory requirements and develop rapport with FDA reviewers and stakeholders.
  • Provide continuing regulatory education and disseminate regulatory information to product development, marketing, and clinical groups.
  • Carry out supervisory responsibilities including interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; and addressing complaints.
  • Provide performance feedback to direct reports and assist in their development.
  • Communicate business-related issues or opportunities to the next management level.
  • Ensure compliance with Health, Safety, and Environmental practices and that resources are available and in good condition.
  • Perform other duties as assigned.
  • A minimum of a Bachelor's Degree in Physical or Biological Science or a related field of study.
  • A very strong understanding of the Medical Device industry.
  • Extensive training and education in Regulatory Affairs related to worldwide product approvals.
  • A minimum of 10 years of experience in all aspects of Regulatory Affairs in the Medical Device Industry.
  • Extensive hands-on experience in product approval applications, crisis management, and FDA inspections.
  • Strong understanding of Medical Device regulations/standards and Quality principles.
  • Excellent written and verbal communication skills.
  • Ability to manage multiple priorities effectively.
  • Strong interpersonal, organizational, and problem-solving skills.
  • Ability to make difficult and often unpopular decisions.
  • Strong negotiation skills with regulatory bodies worldwide.
  • Ability to lead by example.
  • Diversity, equity, and inclusion initiatives
  • Career development opportunities
  • Health and wellness programs
© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service