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Regulatory Affairs Specialist
Ref No.: 20-00133
Location: Franklin Lakes, New Jersey
Our client, a leading medical technology company is looking for a Regulatory Affairs Specialist. This is for an initial duration of 6 months and is located in Franklin Lakes, NJ
This contract position is responsible for processing requests from the international regulatory affairs associates to provide the documentation necessary to complete global product registrations (excludes US and Europe). This position, at the direction of the International Regulatory Affairs Manager, will retrieve international registration requests from the eGPS internal system, identify the documentation required, retrieve the documentation from SAP and other Client systems, and transit the documentation to the requesting international regulatory affairs associate.
1. At the direction of international regulatory affairs manager retrieve registration requests from the Client eGPS system, confirming the product is eligible for registration in the requested jurisdiction.
2. Identify the documentation required to fulfill the registration request. If any discrepancies, contact regional international registration associate and reconcile the issues.
3. Retrieve the necessary documentation from the appropriate Client system or work with the functional representative to request the documentation and transmit to the appropriate international regulatory affairs associate.
4. Track the completion and status of all registration requests in the Client eGPS system.
  • BS degree in science related field.
  • Minimum of 3 years working in medical device company.
  • Minimum of 1 year working with medical device registrations, preferably with vitro diagnostic product registrations for non-US, non-EU countries.
  • Proficient in using Microsoft Office and email software.
  • Proficient in use of Sparta Systems Trackwise software.
  • Proficient in use of SAP to support identification and retrieval of documentation.
  • Strong communication and project management skills.
  • Must be able to handle multiple tasks without compromising attention to details.
  • Strong organizational skills and attention to detail.
  • Working knowledge of technical files and design history files for medical devices, and preferably in vitro diagnostics.
  • Working knowledge of US and European medical device regulations.

Qualified candidates please send your word format updated resume at the earliest to /  Thank You.