Sr. Regulatory Affairs Specialist
Regulatory Affairs Specialist - Temp to Hire
About the Company:
This company has multiple sites across the US with about 500 employees in total. The Torrance site is the smallest location which focuses specifically on the diagnostic space within the company. The RA Specialist will work with a small compliance team and other cross-functional groups.
About the Role:
The Regulatory Affairs Specialist is responsible for implementing the global introduction and continued approval/licensure of new and revised products. They provide subject matter expertise and are responsible for advising and guiding the local organization on regulatory topics. They are also the primary liaison to Marketing and Sales groups with regard to regulatory requirements for marketing communications and other customer-facing communications. These activities will all be done in full compliance with U.S. and international regulatory requirements.
Your skills and experience:
You will have at least five years of progressive experience in domestic/international regulatory submissions, design control systems and/or regulatory compliance. You will also have experience in development and post market support of Class I and II Medical Devices. 510k submission experience, and a BA/BS in the life sciences, are required for this position.
You are a great communicator, flexible, and enjoy working with a team. This position is heavily involved with cross-functional groups so it's important that the RA Specialist is collaborative. This position will be on-site once deemed safe, and partially on-site part for training.
Sthree US is acting as an Employment Business in relation to this vacancy.