Regulatory Affairs

Case studies that describe our placements for regulatory affairs professionals:


Sourcing a regulatory specialist with a science background

Talencio’s client, a global healthcare company, needed a medical device Regulatory Specialist to join their project team. There was a particular requirement to provide regulatory and technical support to their OEM customers specifically for labeling and registration. The ideal candidate would have at least 3 years of related experience and a science background. Although there was a very competitive market for regulatory professionals, Talencio found the perfect candidate. She has a degree in biology and the personality and communication skills to successfully work with multiple cross functional project teams.
 

Finding a regulatory leader

Talencio’s client needed a regulatory affairs professional proficient in 510(K) and CLIA waivers for two of their product lines.  The position required someone with the personality to work hand in hand with their global regulatory team, the ability to work independently to author submissions, interact with the FDA, and effectively communicate with management.  The candidate proved indispensible and was hired by the client to become a Regulatory Affairs Project Manager.
 

Converting a regulatory contractor to an employee
Talencio’s California medical device client required a contract global regulatory affairs specialist to provide a variety of services. After nearly a year and three contract extensions, our client so valued the contractor, they converted him to a full-time role as an employee of their company.
 
Supporting international regulatory approvals

Talencio’s mid-sized medical device client was seeking regulatory approval to sell its product outside of the U.S.  Talencio placed a highly specialized contractor who completed the necessary international regulatory filings.  The company was extremely satisfied with her work and extended her for additional work in this regard.  Ultimately, the client converted the contractor to an employee.

 
Supporting Pacific Rim regulatory efforts

Talencio’s client, a mid-sized medical device company, required a regulatory guru with Asia Pacific experience.  Talencio provided a contractor who worked 10 years in China and Japan.  He conducted gap assessments between technical files and DHR/DMR records, technical file revisions and regulatory document revisions.  Due to the success of this effort, the client has continued to use Talencio for much of their regulatory contract needs.

 

Building core regulatory processes

Talencio’s client, world-wide leader in advanced medical technologies, required support for change order processing and other core regulatory tasks.  The position focused on informed execution and less on strategy.  The contractor worked on FDA submissions for both PMA’s and 510(K)’s, including original submissions and subsequent revisions/supplements.  She interpreted existing or new regulatory requirements as they related to the client’s products and procedures, clinical studies, testing, and records keeping.  She provided input to development teams to assure that FDA requirements were incorporated as part of the development process.

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