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Senior Regulatory Affairs Program Lead

Company Name: Johnson & Johnson
Location: Irvine, CA 92602
Job Type: Full-Time
Contact Name: Lisa Keenan
Phone: 949-923-4789
Fax:
Email:  This email address is being protected from spambots. You need JavaScript enabled to view it.
Salary: $105K to $120K depending on experience

Job Description

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.

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.

Job Requirements

Qualifications:

  • 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.

 

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