Director, Medical Affairs, Electrophysiology

Johnson & Johnson Innovative Medicine•Irvine, CA
•$164,000 - $305,900

About The Position

Johnson and Johnson is seeking a Director, Medical Affairs, Electrophysiology to provide therapeutic and clinical expertise in support of the development of medical devices for the treatment of arrhythmias and structural heart disease. This role involves providing strategic input on long-term product opportunities, working with Scientific Affairs on evidence generation, and collaborating with R&D, marketing, and commercial teams during product development and launches. The Director will build relationships with key customers and stakeholders such as Key Opinion Leaders, surgeons, and regulatory agencies to understand industry trends and unmet medical needs.

Requirements

  • Bachelor's degree in Medicine, Biomedical/Mechanical Engineering, or equivalent life sciences/technical engineering discipline.
  • Minimum 10 years of relevant business experience in product development within the Cardiovascular industry.
  • Minimum 3 years of relevant experience directly in Medical Affairs.
  • Proven track record of the ability to learn complex technology/clinical applications.
  • Demonstrated success in medical data generation, interpretation, and publications.
  • Excellent strategic thinking, communication, and stakeholder‑management skills.
  • Strong knowledge of regulatory, compliance, and ethical requirements governing Medical Affairs.
  • Strong leadership skills and demonstrated ability to build successful relationships globally.
  • Strong communication and negotiation skills.
  • Proven ability to collaborate well in a highly matrixed environment.

Nice To Haves

  • Advanced degree (MD, PharmD, or PhD in Medicine, Biomedical Engineering, or equivalent life sciences).
  • Previous Medical Affairs and/or Medical Science Liaison experience in a regulated, commercial medical device business.
  • Previous clinical experience in the electrophysiology space.
  • Minimum 10 years of experience supporting clinical cases and proctoring cases.

Responsibilities

  • Work with business partners to influence regulatory and commercial strategy, support product development, and manage pre- and post-approval clinical studies.
  • Lead clinical study support, including case support plans, physician and field training, data analysis, and publication support.
  • Support commercial platform launches by activating sites and collecting physician feedback on product performance.
  • Contribute to the execution of product or procedural evidence generation strategies.
  • Participate in governance forums including business unit leadership and product core teams.
  • Engage Key Opinion Leaders, Professional Societies, and Payers to identify healthcare trends.
  • Provide scientific expertise for clinical trial design, analysis, and reporting.
  • Review and escalate adverse events from clinical studies with the Medical Safety team.
  • Prepare clinical investigation reports for regulatory submissions and publication.
  • Provide medical insights for product risk assessments and approve final risk management reports.
  • Account for medical content in internal product documentation and regulatory submissions.
  • Approve Design History Files, Technical Guides, and Clinical Evaluation Reports.
  • Review and approve educational, promotional, and reporting materials.

Benefits

  • Competitive compensation
  • 401k
  • Pension
  • Medical insurance
  • Dental insurance
  • Vision insurance
  • Exercise reimbursement
  • Flexible time off
  • Paid volunteer leave
  • Parental leave
  • Long-term incentive program
  • Vacation (120 hours/year)
  • Sick time (40-56 hours/year depending on location)
  • Holiday pay including floating holidays (13 days/year)
  • Work, Personal and Family Time (up to 40 hours/year)
  • Bereavement leave
  • Caregiver leave
  • Military Spouse Time-Off
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