Johnson & Johnson Careers
Senior Regulatory Affairs Program Lead
Requisition ID: 4742181017
The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Johnson & Johnson, is recruiting for a Senior Regulatory Affairs Program Lead for International Registration, as part of the Regulatory Affairs Lifecycle Innovation (RALI) team, located in Irvine, CA.
The CSS Group consists of six diverse businesses including Acclarent, Advanced Sterilization Products (ASP), Biosense Webster (BWI), Codman Neurovascular, Mentor, and Sterilmed. The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology (EP), Neurovascular, Breast Aesthetics, and Reprocessing.
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.
- A minimum of Bachelor’s degree is required, preferably in a science or technical discipline. A minimum of 6 years of related Regulatory experience is required.
- Familiarity with Title 21 of the US Code of Federal Regulations Parts 800-1299 (21 CFR 800-1299) is required.
- Experience in the application of US Federal Food, Drug, and Cosmetic Act (FD&C) Section 510(k) is preferred.
- Experience in the application of the European Medical Devices Directive (93/42/EEC as amended by 2007/47/EC) and CE marking is required; EU MDR familiarity is preferred.
- Experience in the application of Quality Management System Standard ISO 13485 is required.
- Familiarity with Risk Management Standard ISO 14971 is required.
- Direct experience with international medical device registration is required.
- Experience with change assessments for internationally marketed medical devices is preferred.
- Demonstrable track of successfully managing multiple projects simultaneously is required.
- Previous experience working with globally dispersed affiliates and stakeholders is preferred.
- Excellent written and oral communication skills are required.
- Good analytical thinking, problem solving, and investigative skills are required.
- Ability to lead others.
- Supervisory experience required.
- Proficiency in Microsoft Office and all related applications is required.
- This position will be based in Irvine, CA and may require up to 10% domestic and/or international travel.
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.
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