Johnson & Johnson Careers
Senior Regulatory Affairs Program Lead
Requisition ID: 5855190926
CERENOVUS, Johnson & Johnson’s Neurovascular Division (CNV), a member of the Medical Device group, is recruiting for a Senior Regulatory Affairs Program Lead to be based in Miami, FL; Irvine, CA; or Remotely.
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 Program Lead is responsible for providing independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches. The Senior Regulatory Affairs Program Lead will lead the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers. The Senior Regulatory Affairs Program Lead will guide conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials and help to define data and information needed for regulatory approvals in conjunction with cross-functional product development teams.
- Be responsible for providing regulatory guidance to project teams and will be responsible for assessing device/manufacturing/packaging & labeling changes, developing regulatory strategies and writing/coordinating/compiling and submitting regulatory documents to FDA and other Regulatory Agencies.
- Create and maintain documents including PMA/PMA Supplements/30 Day Notices, IDEs, 510(k) submissions, Change Notifications, Technical Files/Design Dossiers (CE Mark) and responses to regulatory agencies’ questions and other correspondence.
- Act as regulatory liaison to U.S. Food & Drug Administration for regulatory submissions and other projects as required
- Effectively lead and collaborate with colleagues, OUS Affiliates, and external partners where required to ensure team objectives and milestones are met in a timely manner.
- Ensure compliance with regulatory agency regulations and interpretations.
- Develop timelines for submissions under the direction of senior regulatory affairs staff.
- Develop solutions to a variety of problems of high scope and complexity.
- Participate in the development, review and approval of product labeling.
- Perform other duties as assigned by the manager of this position
- May be responsible for overseeing the work of lower level Regulatory Affairs Specialists or Coordinators.
- A minimum of a Bachelor’s degree with at least 4 years of experience in related field and/or equivalent experience in the medical device industry is required.
- Practical experience in a Medical Device Regulatory Environment is required.
- Knowledge of US and European regulatory processes is required.
- Experience with 510(k) submissions or PMA-related submissions is required.
- Experience with class II and III technical files in the EU is required.
- Experience in change management is preferred.
- Knowledge of international medical device requirements (China, Japan, Australia, Brazil, Russia, etc.) is preferred.
- Experience working as a member of a team in a timeline-driven environment with limited supervision is required.
- Prior interaction with the FDA and Notified Bodies is preferred and other worldwide agencies preferred.
- Excellent written, verbal communication and presentation skills
- Ability to partner and influence key stakeholders on NPD and Lifecycle teams is required.
- Leverages scientific and technical understanding of medical devices to serve as a resource and strategic partner for development and planning throughout the product lifecycle in applicable markets is required.
- Demonstrates the ability to contribute to the development of effective and results-oriented regulatory strategic plans that are in line with business objectives is required.
- Consults with others to understand the benefits, risks, and Credo-based impact associated with decision alternatives before making decisions is required.
- This position can be located in either Miami, FL; Irvine, CA; or Remotely and may require up to 5 % domestic and/or international travel.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
North America-United States, North America-United States-California-Irvine
Medical Device Business Services, Inc (6029)