Johnson & Johnson Careers
Senior Regulatory Affairs Specialist, International Registrations
Requisition ID: 9715180815
Advanced Sterilization Products is recruiting for a Senior Regulatory Affairs Specialist, responsible for international registrations, to be located in Irvine, CA.
Healthcare-associated infections (HAIs) have a devastating personal and economic impact, claiming the lives of 99,000 people in the U.S. each year at a cost of up to $45 billion. Ensuring that all surgical devices are properly sterilized is one way healthcare workers can help reduce the incidences of HAIs, and Advanced Sterilization Products (ASP) has been partnering with hospitals for decades to safeguard patient health and safety. ASP has a strong track record of designing and delivering innovative infection-prevention solutions, from low-temperature sterilization to high-level disinfection, and is a global market leader setting the standard in sterilization.
Johnson & Johnson announced that it has received a binding offer from Fortive Corporation to acquire Advanced Sterilization Products(ASP). If the offer is accepted, the proposed transaction would be expected to close no later than early 2019, subject to customary closing conditions and regulatory approvals. Should you receive and accept an offer for this position, upon completion of the transaction, your employment with ASP will transfer to Fortive according to local law and will be governed by Fortive’s employment processes, programs, policies and benefits plans.
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. The Senior Regulatory Affairs Specialist – International Registrations provides 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.
- Under minimal supervision, 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.
- 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.
- Update and maintain FDA Establishment Registration and Listing, as well as State licensing
- 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.
- Review and approve promotional materials.
- 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 are required.
- Good analytical thinking, problem solving and investigative skills are required.
- Proficiency in Microsoft Office and all related applications is required.
- This position will be located in Irvine, CA and may require up to 10% domestic and/or international travel.
Advanced Sterilization Products (ASP)