Senior Regulatory Affairs Specialist - Medtech Surgery

Johnson & Johnson Johnson & Johnson · Pharma · Cincinnati, OH +1

This role is for a Senior Regulatory Affairs Specialist in the MedTech Surgery division at Johnson & Johnson. The primary focus is on ensuring medical devices meet regulatory requirements in the US and globally, preparing and submitting regulatory documents, and maintaining device registrations throughout their lifecycle. The role involves collaboration with internal departments and global partners, monitoring regulatory changes, and providing support for audits. Experience with US Class II device submissions and active medical devices is required, with a preference for software, cybersecurity, and electromagnetic evaluation submissions.

What you'd actually do

  1. Prepare and submit regulatory documents, including applications for new product registrations and maintenance of existing registrations, to US FDA and EU Notified Bodies).
  2. Collaborate with global regulatory partners to drive innovation and prepare global regulatory submissions.
  3. Maintain device registrations and licenses throughout product lifecycle.
  4. Support product lifecycle.
  5. Evaluate proposed device changes for regulatory requirements and perform required regulatory submissions.
  6. Assist in the development of multi-country regulatory strategy.
  7. Monitor changes in regulations.
  8. Maintain and update strategy based upon regulatory changes in responsible jurisdictions.
  9. Provide regulatory support with teammates for internal and external audits (e.g. MDSAP).

Skills

Required

  • Bachelor's Degree
  • 4+ years of related professional Regulatory Affairs experience
  • Ability to comprehend principles of engineering, physiology and medical device use
  • Experience in reviews of engineering, manufacturing, marketing, labeling and clinical documents for regulatory compliance
  • Exceptional self-education skills
  • Strong verbal communication and regulatory/medical writing skills
  • Ability to effectively manage multiple projects and priorities
  • Leadership traits
  • Results oriented
  • Experience with US Class II device submissions

Nice to have

  • Science or Engineering discipline
  • 2+ years with Advanced Degree
  • Experience with active medical devices, including software, cybersecurity and electromagnetic evaluation submissions
  • Regulatory Certification (such as RAC from the Regulatory Affairs Professionals Society)

What the JD emphasized

  • required
  • highly desired
  • related professional Regulatory Affairs experience required
  • Exceptional self-education skills required
  • Strong verbal communication and regulatory/medical writing skills
  • Ability to effectively manage multiple projects and priorities
  • Experience with US Class II device submissions