Ramping up Regulatory Affairs

KellyOCG helps leading medical device organization access quality regulatory affairs talent with a high-touch, expert-driven FSP solution.

In light of a massive regulated recall issued by the U.S. Food and Drug Administration, an international medical device company was forced to repair approximately 300,000 devices at over 4,000 sites across the U.S. and Puerto Rico. Facing the impending mandatory project, the company initially sought to outsource the entire remediation to third-party repair companies. However, because it was important to the client that they own and certify the work product outcome themselves, the consultants at KellyOCG recommended a staff augmentation approach to be more effective.

Initially, the client chose to partner with multiple talent vendors, including KellyOCG. At the end of the first project phase, however, it was clear that we were outperforming the other suppliers, and soon the company engaged us to manage the entire remediation effort.

The Company

A U.S.-based global pharmaceutical and medical device company, with approximately 15,000 employees.

The Challenge

After the FDA issued a recall of nearly 300,000 devices, the company was forced into a massive remediation project, requiring extensive project management and recruitment support.

The Solution

KellyOCG leveraged its engineering field services expertise and robust supplier network to handle the project management and talent recruitment for the entire remediation project.

The Result

With the implementation of the end-to-end solution, the company gained control and visibility of key project performance metrics, access to, and retention of the talent required, and achieved 98% on-time completion.

Our Value

  • Quick access to quality talent
  • Niche expertise in engineering field services
  • Increased retention of intellectual capital
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