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.
Qualifications
A minimum of Bachelor's degree is required, preferably in a science or technical discipline.
A minimum of 4-6 years of related Regulatory experience is required.
Experience with FDA regulations for medical devices is required.
Experience working with FDA 510(k)s, PMA, etc. is required.
Knowledge of the European MDD, MDR and CE marking is preferred.
Familiarity with Risk Management Standard ISO 14971 is preferred.
Direct experience with international medical device registration is preferred.
Experience with change assessments for internationally marketed medical devices is preferred.
Project Management experience is preferred.
Demonstrated leadership, organizational, and planning skills with the ability to work cross-functionally with a culturally-diverse work force and customer base is preferred.
Excellent written and oral communication skills are required.
Good analytical thinking, problem solving, and investigative skills are required.
Proficiency in Microsoft Office and all related applications is required.
The primary location for this position will be in Irvine, CA.
This position may require up to 10% domestic and/or international travel.
This job posting is anticipated to close on 5.27.2024. The Company may however extend this time-period, in which case the posting will remain available on to accept additional applications.
For U.S. applicants, in accordance with applicable disclosure requirements, the anticipated base pay range for this position is $104,000 to $140,000. Additional information can be found through the link below. For additional general information on company benefits, please go to:
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.