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Regulatory Specialist - 64340952 - TT

Job Code: 64340952
Job Location: Miami, FL
Category: Quality Engineering
Last Updated: 07/09/2019
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Job Description:
The Regulatory Specialist II will support the Hematology, Urinalysis, and Flow Cytometry business units in meeting conformity to the EU In Vitro Diagnostic Regulation (IVDR). As a regulatory process expert supporting the IVDR teams, implements regulatory strategies for IVDR activities; provides regulatory leadership in experimental designs, data analysis and product labeling as related to registration and commercialization of in vitro diagnostic devices; collaborates with the regulatory staff from other business units, companies, government agencies and Product Regulatory Subcommittees as needed to develop harmonized policies, procedures and work instructions for IVDR compliance.
Bachelor’s degree (or foreign equivalent) in Science, Regulatory Affairs, or Engineering plus 5 years of experience in the offered position or related.
All candidates moving forward must have the following:
• 3-5 years in Diagnostics Regulatory affairs (more than 10 year experience is considered overqualified)
o Must be able to articulate the differences between IVDD – IVDR
o Regulatory experts that understand the new FDA directive within medical device manufacturing regulations
o Must have experience in diagnostics / medical device (pharma is not the same, does not translate well)
• Excellence written communication skills (writing samples could be helpful to sell your candidates) This is a long term temp assignment, no conversion opportunity. The team does not have time to train they need candidates that are turn-key ready!
For more information about this position, please contact the Entegee New Hope, MN office at 763-577-9000 or
Please reference job # 64340952TT
Equal Opportunity Employer


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Entegee is an equal opportunity employer. Entegee considers applicants for all positions without discrimination on the basis of race, color, religion, sex, national origin, age, marital or veteran status, disability, or any other legally protected status. No question in the website is used for the purpose of limiting or excluding any applicant's consideration for employment on any basis prohibited by local, state, or federal law.

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