Johnson & Johnson Careers
Senior Regulatory Affairs Specialist, International Registrations
Requisition ID: 2343180919
Johnson & Johnson’s Cardiovascular & Specialty Solutions (CSS) Group within Medical Devices is recruiting for a Senior Regulatory Affairs Specialist, International Registrations located in Irvine, CA.
The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology, Surgical and Non-Surgical Aesthetics, and Reprocessing.
You, the Senior Regulatory Affairs Specialist, 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.
You, the Senior Regulatory Affairs Specialist – International Registrations, will:
- Under minimal supervision, 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.
- Under minimal supervision, create detailed international regulatory plans in concert with regional Regulatory contacts.
- Ensure compliance with applicable international regulations and standards
- Ensure preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
- Under minimal supervision, prepare responses to health authority questions and other Regulatory correspondence.
- Gather and assemble 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 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 Bachelor’s degree and a minimum of 4 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.
- Familiarity with application of US Federal Food, Drug, and Cosmetic Act (FD&C) Section 510(k) is required.
- Experience in the application of the European Medical Devices Directive (93/42/EEC as amended by 2007/47/EC) is required; EU MDR familiarity is desired.
- Familiarity with 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 (especially China, Japan, Canada, Australia, Brazil, and Russia) is required.
- Experience with change assessments for internationally marketed medical devices is preferred.
- Excellent written and oral communication skills at all levels and internal business partners are required.
- Good analytical thinking, problem solving, and investigative skills are required.
- Proficiency in Microsoft Office and all related applications is required.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
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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