Quality/Risk Management, US Regulatory Affairs, Worldwide Regulatory Affairs
Senior Regulatory Affairs Program Lead(Job Number: 6249180708)
Advanced Sterilization Products is recruiting for a Senior Regulatory Affairs Program Lead 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 steam 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 Program Lead, will provide administrative and technical support to regulatory affairs leadership in order to facilitate compliance with all FDA and other U.S. and international regulatory requirements. The Senior Regulatory Affairs Program Lead provides direct Worldwide Regulatory support to lifecycle management and new product development cross-functional project teams, including in-depth team involvement for complex projects; evaluation of proposed product modifications for global Regulatory impact; and documentation of required change impact assessments and Regulatory Strategies.
You, the Senior Regulatory Affairs Program Lead will:
Write, coordinate, compile, and submit Regulatory documents to FDA and other Regulatory Agencies, including International Authorities. Also includes the preparation of international documents, including Technical Files.
Work with Management to ensure rapid and timely approval of new products and continued Regulatory support of marketed products.
Create detailed Regulatory Plans. Includes in-depth team involvement and Core Team membership for complex projects.
Evaluate proposed product modifications for Regulatory impact on a worldwide basis, completing Regulatory Assessments as needed.
Ensure compliance with FDA and other applicable regulations and standards
Ensure preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
Prepare responses to FDA questions and other Regulatory correspondence.
Gather and assemble information necessary for submissions in accordance with regulations and relevant guidelines.
Require use and application of Regulatory concepts, practices and techniques.
Provide solutions to extremely complex problems.
Provide regulatory guidance to project teams.
Participate in the development, review and approval of product labeling.
Provide support to inspections/audits by FDA, the notified body or other international regulatory bodies by producing requested documents or answering any inquiries for information.
Review and approve promotional materials.
A Bachelor's degree and a minimum of 6 years of related Regulatory experience is required.
Experience in the application of 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 required.
Experience authoring 510(k) Premarket Notifications with successful product clearance is strongly preferred.
Experience with change assessments for 510(k)-cleared medical devices is strongly 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.
Experience in the application of Quality Management System Standard ISO 13485 is required.
Knowledge of Risk Management Standard ISO 14971 is required.
Familiarity with International medical device registration requirements (China, Japan, Canada, Australia, Brazil, Russia, etc.) is required.
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 20% domestic and/or international travel.
Primary Location: North America-United States-California-Irvine