Advanced Sterilization Products is recruiting for a Senior Regulatory Affairs Specialist 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 Specialist 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 Regulatory Affairs Specialist III 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 Specialist will:
Under minimal supervision, coordinates, compiles, and submits Regulatory documents to FDA and other Regulatory Agencies, including and 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.
With minimal supervision, provide Regulatory support to project teams.
With minimal supervision, 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 interpretations.
Prepare responses to FDA questions and other Regulatory correspondence.
Develop solutions for problems of moderate scope and complexity.
Participate in the development, review and approval of product labeling.
Provide audit support for internal and third party audits.
Review and approve of promotional materials.
A Bachelor's degree and a minimum of 4 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 preferred.
Experience with change assessments for 510(k)-cleared medical devices is strongly preferred.
Experience in application of the European Medical Devices Directive (93/42/EEC as amended by 2007/47/EC) is required.
Familiarity with 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.
This position will be located in Irvine, CA and may require up to 10% domestic and/or international travel.
Primary Location: North America-United States-California-Irvine