Senior Regulatory Affairs Program Lead
Company: Disability Solutions
Location: Irvine
Posted on: May 3, 2024
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Job Description:
The Cardiovascular & Specialty Solutions (CSS) Group, part of
the Medical Tech sector within Johnson & Johnson, is recruiting for
a Senior Regulatory Affairs Program Lead for International
Registration, as part of the Regulatory Affairs Global Execution
team, located in Irvine, CA. At Johnson & Johnson, we believe
health is everything. Our strength in healthcare innovation
empowers us to build a world where complex diseases are prevented,
treated, and cured, where treatments are smarter and less invasive,
and solutions are personal. Through our expertise in Innovative
Medicine and MedTech, we are uniquely positioned to innovate across
the full spectrum of healthcare solutions today to deliver the
breakthroughs of tomorrow, and profoundly impact health for
humanity. Learn more at The Senior Regulatory Affairs Program Lead
- International Registrations, will provide administrative and
technical support to regulatory affairs leadership in order to
facilitate compliance with U.S. and international regulatory
requirements. You will provide direct Worldwide Regulatory support
to lifecycle management and new product development/new product
introduction international product registrations., In this role,
you will: --- Write, coordinate, compile, and submit Regulatory
documents to competent authorities, notified bodies, Regulatory
Agencies, and international business partners. Includes the
preparation of key market international documents, including
Technical Files. --- Work with Management to ensure rapid and
timely approval of new products and continued Regulatory support of
products marketed outside the United States. --- Create detailed
international regulatory plans in concert with regional Regulatory
contacts. --- Evaluate proposed product modifications for
international Regulatory impact, completing Regulatory Assessments
as needed. --- Ensure compliance with applicable international
regulations and standards --- Ensure preparation of necessary
outlines, summaries, status reports, memos, graphs, charts, tables,
and slides. --- Assist with responses to health authority questions
and other Regulatory correspondence. --- Gather and compile
information necessary for submissions in accordance with
regulations and relevant guidelines. --- Update and maintain
product eligibility to ensure right product/right country. ---
Requires use and application of Regulatory concepts, practices and
techniques. --- Provide solutions to complex problems. --- Provide
regulatory guidance to project teams, as applicable. ---
Participate in the development, review and approval of
international product labeling. --- Provide support to
inspections/audits by government agencies and the notified body by
producing requested documents or answering any inquiries for
information.
Keywords: Disability Solutions, Tustin , Senior Regulatory Affairs Program Lead, Other , Irvine, California
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