Sr. Regulatory Affairs Specialist

Role: Regulatory Affairs Sr Spec

Location: Irvine, CA - 92606

Duration: 9 Months on W2 (Possibility to convert to FTE for right candidate).

Call Summary

• 100% Onsite role.
• Open to National search (Relocation at own expense).
• International Regulatory Experience.
• Understand requirements from an international standpoint. Understand what documents need to be provided and what are not. Must not give too much information as well. Just to the point where work must be done and nothing additional to it.
• They must have a US or EU, and a significant amount of international experience.
• The major markets are the US, EU, China, and Japan. For example, If they have international experience, they must know that South Korea is heavy on biocompatibility; from a biocompatibility standpoint, what extra documents are needed.
• Must be able to understand product development, understand the lifecycle of a product.
• Some EU experience does help to understand how to find documents.
• Regulatory submissions exp is a plus, not mandatory.
• Day to Day: They will get questions from in-country RA saying they need to do renewal in India and they need ER Matrix, packaging, testing, sterilization, and shelf life. This person will go into the database and look at the device, find all the documents, and give it to RA for India. This is just one example.
• Understanding of the design history file is needed so that they know what documents are needed from a development standpoint.
• Minimum 3 years of experience; manager prefers quality over quantity in terms of exp.
• Screening questions: International experience and EU/US experience.
• Class 2 or Class 3 Medical Device exp is required. Pharma or any other will not work.
• System/Application Software: Ignite
• Team player and ability to take ownership and cover for team members as and when needed.
• This may strongly turn into full-time, so candidates who do not need sponsorship will be given preference. So the manager prefers GCs/Citizens.