DJO Global is a leading global developer, manufacturer and distributor of high-quality medical devices and services that provide solutions for musculoskeletal health, vascular health and pain management. We are currently seeking a Regulatory Affairs Specialist 2 at our global headquarters in Vista, CA.
Summary: Responsible for researching and executing regulatory tasks of moderate scope, complexity and risk. Performs regulatory due diligence of moderate complexity such as Class II products and requires the use of discretion and independent judgment when making decisions. Tasks may include proficiency at assignments such as establishment registration & listing, export certificate submissions, international product registrations, new product development support as well as the ownership of medium sized Regulatory Affairs projects.
Essential Duties and Responsibilities:
• Assist other team members with requests involving international registrations.
• Must demonstrate ability to interact with agencies in other countries and ability to communicate effectively
• Must be well-organized and able to track several registrations concurrently
• Good communication skills (phone skills) and strong computer skills are necessary
• Must have the ability to follow through with requests and be resourceful in getting answers
• Perform establishment registration and device listing
• Obtain export certificates as needed.
• Additionally, support all RA teams as needed. Provide input for RA functions involving compliance issues, change orders and design history files.
• Other duties may be assigned.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Bachelors Degree in a science discipline; or equivalent combination of education and experience. Master’s degree preferred.
• 3+ years of QA or RA Experience working in an FDA regulated or legal industry.
• Thorough knowledge of FDA regulations, guidance, and policy regarding medical devices.
• RAC preferred.
ABOUT DJO GLOBAL
Headquartered in San Diego, CA (Vista), DJO Incorporated is a leading global provider of high-quality, orthopedic devices, with a broad range of products used for rehabilitation, regeneration, pain management and physical therapy sold through our DonJoy, Empi, CMF, Aircast / Procare, and Chattanooga Group business units.
We are the largest non-surgical orthopedic rehabilitation device company in the United States and among the largest globally. We also develop, manufacture and distribute a broad range of surgical reconstructive implant products through our DJO Surgical business unit.
We believe that our strong brand names, comprehensive range of products, focus on quality, innovation, customer service, extensive distribution network, and our strong relationships with orthopedic and physical therapy professionals have contributed to our leading market positions.
DJO is a portfolio company of the Blackstone Group.
DJO - 2 years ago