Regulatory Affairs Specialist – ValidIT Solutions LLC – Menlo Park, CA

Prepares robust regulatory applications supporting International geographies to achieve departmental and
organizational objectives. Supports EU MDR transition activities and maintains product technical files.
 Creates, reviews and approves engineering change order and prepare worldwide Regulatory assessments
 May act or assist as a regulatory representative on core product development teams, communicates
regulatory requirements and impact of regulations to the development team. Provides guidance and
expertise.
 May act or assist as liaison between the Company and the various appropriate regulatory agencies,
ensuring that communications on both sides are germane, specific and convey all necessary detail.
 Maintains ongoing surveillance and analysis of all pertinent domestic and international medical device
regulations to ensure submission requirements world-wide are current, up-to-date and are entered into
regulatory submission data base and file systems. Ensures that information of such regulations and
requirements, especially those that are new or modified, are distributed to appropriate personnel.
 Reviews device labeling and marketing materials for compliance with submissions and applicable
regulations.
 Supports the product release process by completing requests for product release.
 Conducts reviews of product and manufacturing changes for compliance with applicable regulations.
 Reviews protocols and reports to support regulatory submissions.
 Support all Company initiatives as identified by management and in support of Quality Management
Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
 Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory
requirements, Company policies, operating procedures, processes, and task assignments. Maintains
positive and cooperative communications and collaboration with all levels of employees, customers,
contractors, and vendors.
 Performs other related Regulatory Affairs duties and responsibilities, as assigned.

Job Type: Contract

Pay: $35.00 – $64.00 per hour

Schedule:

• 8 hour shift

Contract Length: