Regulatory Affairs at The Judge Group Inc. in Palo Alto, California

Job Description:

Location: Palo Alto, CA

Salary: $50.00 USD Hourly - $68.00 USD Hourly

Description: Our client is currently seeking a Regulatory Affairs for a 12 month + contract.


Hybrid position, 2 days in office (Palo Alto, CA).


Position Description:


*Perform the coordination and preparation of regulatory submissions for brachytherapy devices and software devices according to regulatory requirements


* Identifies, analyzes and implements country specific requirements necessary for product related submissions.


*Recommend strategies for earliest possible approvals for marketing applications


* Performs regulatory projects or acts as a member of the project steering group.


* Submits required documentation/information to local authorities or internal.


* Initiates and escalates necessary activities if deviations are identified.


* Ensures creation of adequate documentation for audits/inspections.


* Performs training within the organization in country specific regulatory requirements, if applicable. *Write and maintain submissions procedures, work instructions and templates relevant for maintaining regulatory compliance.


* Performs review of promotional material for regulatory compliance according to country specific requirements. Impacts: Is expected to adopt existing concepts, methodologies, etc. in order to create and open up new ways of approaching and fulfilling specific internal and external client requests or project requirements.


Experience: 5-8 years.


Product Registration Experience:


• Experience with FDA 510(k) applications, Health Canada license applications and EU MDR technical files


• Knowledge of regulatory guidance documents and requirements for product classification determination, FDA 510(k) submissions, Health Canada license Applications and EU MDR technical files.


• Knowledge of regulatory guidance documents (FDA, Health Canada, EU MDR) for determining if a product change requires a regulatory submission (software and hardware devices).


• Working knowledge of ISO 13485, IEC 62304, IEC 62366, ISO 14971, ISO 10993-1 as evidenced by coursework or submissions that required use of each standard


Teamwork and collaboration: Excellent communication and interpersonal skills to collaborate across departments and interact with design and development teams.


Experience with Business Tools: Proficient in utilizing business tools such as: E-mail, Microsoft Word, Excel, PowerPoint, and Adobe Pro.



Contact: eronan@judge.com


This job and many more are available through The Judge Group. Find us on the web at www.judge.com