Senior Regulatory Affairs Project Lead

14 May, 2022

Jobs

Senior Regulatory Affairs Project Lead

Johnson & Johnson
Miami, FL/Irvine, CA

Job Description

CERENOVUS, Johnson & Johnson’s Neurovascular Division (CNV), a member of the Medical Device group, is recruiting for Senior Regulatory Affairs Project Lead with a preferred location of Miami, FL or Irvine, CA. Remote work options in the United States may be considered on a case-by-case basis and if approved by the Company.

Every six seconds someone dies from a stroke. Stroke can be caused either by a clot obstructing the flow of blood to the brain (ischemic stroke) or by a blood vessel rupturing and preventing blood flow to the brain (hemorrhagic stroke). CERENOVUS is committed to changing the trajectory of stroke by providing physicians with innovative technologies to push the boundaries of what’s possible in neurovascular intervention. CERENOVUS offers a broad portfolio of devices used in the endovascular treatment of hemorrhagic and ischemic stroke.

The Senior Regulatory Affairs Project Lead will develop and implement strategies and processes to achieve timely commercialization of innovative medical products in compliance with applicable regulations and standards.

Key Responsibilities:

Under limited supervision and in accordance with all applicable international, federal, state and local laws/regulations/requirements and Corporate Johnson & Johnson procedures and guidelines:

  • Ensure compliance with global regulations and regulating agencies.
  • Interpret the intent of regulations and policies and provide such information to project teams and management.
  • Represent Regulatory Affairs on cross-functional project teams.
  • Lead the submission of licenses and authorizations for new products and changes to existing products.
  • Develop 510k/PMA submissions and US assessments for US Class II and III medical devices.
  • Develop Technical Documentations and EU assessments for EU Class III medical devices.
  • Lead discussions with the FDA/European Notified Bodies as needed, including pre-submission identification of requirements and strategy and post submission queries to ensure timely approval.
  • Gather and assemble information necessary for complex submissions
  • Assist in the development of processes and mentorship of regulatory colleagues
  • Provide Regulatory Affairs support during internal and external audits.
  • Work closely with Research and Development, Medical Affairs, Clinical Research, Quality Engineering, Marketing, Labeling Center of Excellence, as well as Global Regulatory Affairs affiliates
  • Connect by encouraging and supporting internal collaboration across levels, creating effective solutions.

Qualifications

Education:

  • A minimum of a B.A./B.S. within a technical or scientific field is required

Experience And Skills:

Required:

  • A minimum of 4 years of demonstrated ability in a related field and/or equivalent experience in the medical device industry is required
  • Knowledge of US and European regulatory processes is required
  • Experience in preparing regulatory submissions in the US or EU is required
  • Experience working as a member of a team with limited supervision is required
  • Strong written & verbal communication and presentation skills is required
  • Experience communicating with the FDA and/or Notified Bodies is required

Preferred:

  • A minimum of 2 years of medical device regulatory experience is preferred
  • A demonstrated track record of developing and implementing global regulatory strategies that align with business results is preferred
  • Previous experience with EU Class III medical devices is preferred
  • Knowledge of international medical device requirements (China, Japan, Australia, Brazil, Russia, etc.) is preferred
  • Experience communicating with the FDA and Notified Bodies is preferred
  • Advanced degree with 2 years of related experience is preferred

Other:

  • This position can be performed remotely or at a J&J facility
  • May require 5% travel annually with possibly some international travel
  • May act as the main contact with regulatory agencies and/or health authorities

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Learn more here

Job posted: 2022-05-14