What are the responsibilities and job description for the Regulatory Specialist Sr position at Experis?
Overview
Experis, a ManpowerGroup company has an exciting contract opportunity for Regulatory Specialist Sr. This position is a 12 - 18 Months contract role for one of our key clients, a global medical device and healthcare company that seeks to bring life-changing health technologies to the people who need them all over the world.
Position: Regulatory Specialist Sr
Location: Pleasanton, CA 94588
Duration: 12 - 18 Months (Possible Extension)
Description:
- Provide regulatory support for Rebranding, Labeling and Packaging Update Projects for Heart Failure products
- Initiate, Review and Approve Change Orders related to various assigned Projects
- Communicate with International Regulatory Affairs affiliates and provide adequate information for initiating Regulatory Assessments
- Navigate and provide regulatory input to the develop approaches for Packaging and labeling updates
- Supports a collaborative environment to align with other cross functional individuals
- Active follow-up on the progression of day-to-day documentation activities required to successfully and timely complete the deliverables
- Supports the Technical Publications team to update Labels and IFUs and align with the requirements
- Supports the Packaging team to update Packaging design and drawings and align with the requirements
- Stay abreast of all pertinent regulatory affairs/ quality system issues specific to projects
- Applies skill set to navigate through the various regulatory operations activities as necessary
Mandatory Requirements
- Medical Device Regulatory Affairs (2 years)
- S. in Engineering or Life sciences or an alternative Bachelor's degree program with experience in Engineering or Life Sciences
- A Masters degree in Regulatory Affairs can substitute for years of experience
- Cross functional understanding of Design Control, Packaging, Labeling, Risk Management, Clinical Affairs as required to support RA submissions
Apply Today
Recommended Skills
- Assessments
- Clinical Works
- Engineering
- Labeling
- Risk Management
- Sciences
Salary : $64 - $65
Regulatory Specialist
TalentBurst, an Inc 5000 company -
Santa Clara, CA
Sr. Regulatory Affairs Manager
IntelliPro Group Inc. -
Sunnyvale, CA
Sr Manager, Corporate Regulatory Affairs
Corcept Therapeutics -
Redwood, CA
